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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…

Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. investigation by Olympus confirmed the tube sheath is longer than specifications which prevents the clip from being extended. Absence of treatment,…

Olympus has received complaints that the grasping portion of FG-51D forceps can be difficult to open and close. Olympus reviewed approximately 200 complaints globally over the last five years. Subsequent complaint investigation has confirmed that the FG-…

Olympus Medical Systems Corp (OMSC) conducted a postmarket risk assessment of the GFUC140P-AL5. As part of that review, OMSC applied updated FDA guidance for reprocessing validation. OMSC's testing showed that the GF-UC140P-AL5, when reprocessed in the…

The OER-elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Olympus discovered the detergent and alcohol tank tubing…

Olympus previously introduced an annual TJF-Q180V inspection program whereby users are asked to return the TJF-Q180Vs in their possession for inspection. Olympus has reviewed the data obtained via this program and has observed deterioration of the TJF-…