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An official Health Canada notice concerns Single use guide sheath kit. 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 Published 2025-01-23.
What to do now
Contact the manufacturer if you require additional information.
Recall number
76847
Official notice
2025-01-23
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Olympus Medical, Single Use Guide Sheath Kit.
Source & status
Source & status
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Category
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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