Olympus Corporation of the Americas recalls
42 recalls on record · 6 rated Critical · FDA
Every recall we have on record for Olympus Corporation of the Americas, compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Potential for detachment of a distal tip component of the device during use.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
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Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps …
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The…
Potential for rubber fragment detachment during use.
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The…
Potential for rubber fragment detachment during use.
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in…
Complaints of the ceramic tip of the resection sheath breaking have been received.
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 …
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 …
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; …
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; …
Devices which did not undergo thermoforming could deform and lose performance.
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer …
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator…
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. …
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number:…
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS…
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm…
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Colonoscope, Model Number PCF-H190DL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Colonoscope, Model Number CF-Q180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Colonoscope, Model Number CF-H180AL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in…
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures…
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S,…
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150,…
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 …
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
EVIS EXERA III Gastrointestinal Videoscope
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm…
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Bronchovideoscope, Models BF-3C160.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC…
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L,…
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay
Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190,…
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive…
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
BF-3C160: EVIS EXERA Bronchovideoscope
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization