Olympus conducted an investigation into the Single Use Guide Sheath Kits after receiving complaints that the radiopaque tip of the guide sheath component fell off into the patient. Since July 2021, Olympus has received 32 complaints involving intraoperative disassociation of the guide sheath radiopaque tip in which the tip fell off into the patient. Of these 32 complaints, 26 were reported as serious injuries, and 6 were reported as malfunctions. The preliminary findings from Olympus' investigation have identified that the disassociation of the tip from the guide sheath is likely the result of excessive force applied when inserting instruments into the guide sheath, and/or damage to the distal end of the sheath. Olympus reminds users to closely follow the Instructions For Use (IFU) for the Single Use Guide Sheath Kits, especially the inspection directions detailed in sections 9 to 9.2 of the IFU, and the warnings and cautions listed in section 9.3 operation, which instruct users not to force instruments if resistance is encountered. Forcing instruments through the guide sheath can contribute to disassociation of the guide sheath radiopaque tip. Recall Start Date: January 15, 2025
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