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Olympus has received four (4) adverse event complaints of endobronchial combustion during therapeutic procedures with the Olympus bronchoscope model BF-XT190, of which one (1) involved high-frequency therapy equipment. the other three (3) adverse events…

The GIF-1TH190 reprocessing manual has instructions for either High Level Disinfection (HLD) reprocessing or Ethylene Oxide Gas (EOG) sterilization after endoscope cleaning. As a result of testing, Olympus discovered EOG sterilization failures in which…

Olympus is providing updated warning and recommendations after being aware of patients suffering complications from over insufflation including arrythmias, gas embolism, and death during surgical procedures. Recall start date: October 13, 2023

Following repair activities, Olympus uses a water flush of endoscope channels as part of our final endoscope channel inspection, and we subsequently dry the endoscope channels with compressed filtered air. Olympus discovered that our channel air drying…

Olympus is initiating this action after becoming aware of recent reports of infections and positive cultures and inquiries from the FDA regarding these reports. Olympus is reminding users to closely follow reprocessing instructions, including periodic…

Olympus is taking this recall action after discovering that the Thunderbeat's blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position. Olympus is requesting healthcare facilities…

Olympus found that certain lots of the CV-190 do not start up properly and as a result, the image from the endoscope is not displayed when the operations listed below are performed because parts that deviated from the specification were assembled into…

Devices contain di-2-ethylhexyl phthalate (DEHP). Olympus has previously announced on the labeling that the product contains DEHP. Since Olympus has confirmed that alternative products can be provided, Olympus has decided to ask customers to cease using…

Olympus has received three complaints, including one that was associated with an injury, that upon trying to use an Olympus pulmonary endoscope model with an endotracheal tube, the tip became lodged (entrapped) inside the endotracheal tube connector. As…

Manufacturer notification to highlight the following changes: 1. Change conditions for ethylene oxide (EtO) gas sterilization from 12% EtO to 100% EtO. 2. Reusable cleaning brush are no longer compatible for the manual cleaning. single use brushes…

Olympus discovered the MAJ-1444 may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines. Specifically, when the MAJ-1444 is put into the washing case with other…

Olympus has received complaints of endobronchial combustion during therapeutic procedures using lasers or argon plasma coagulation with the Olympus bronchoscope. If endobronchial combustion occurs, patients may suffer internal burn in their airway or…

The tracheal intubation scopes, LF-V and LF-P, have been listed as compatible with Olympus endoscope reprocessors (models OER-pro and OER-elite). the OER-pro endoscope reprocessor was the first Olympus model introduced among this series and was launched…

Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients.…

Olympus has become aware that the single use distal cover MAJ-2315 may cause mucosal injury, become cracked and/or detach from the endoscope during use. Olympus redesigned the distal cover and has observed a decrease in the referenced complaints. Olympus…