CanadaOlympus Resection and Inner Sheaths by Olympus Winter & Ibe GmbH — including catalogue numbers A42011A, A2660T, A2641, A2660, A2642, A22014T, A2666T, A2666, A22014A, A37004A, A4741, A22041T, A22042A, A22043A, A22040A and WA22017A used with OES/ORS 4000, OES Pro and pediatric systems — are affected. They were recalled because Olympus identified complaints of the ceramic tip of the resection/inner sheath breaking, and the company highlights following the inspection, testing and caution sections of the IFU and the resectoscope system manual; contact the manufacturer for additional information.
What's being recalled
Companies: Olympus Winter & Ibe Gmbh, Kuehnstrasse 61, Hamburg, Hamburg, Germany, 22045.
How to identify it
Affected products: OES Pro Hysteroscopy Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A42011A
Affected products: OES 4000 Urology Resectoscope System; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A2660T
Affected products: ORS 4000 Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A2641
Affected products: ORS 4000 Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A2660
Affected products: ORS 4000 Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A2642
Affected products: ORS 4000 Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22014T
Affected products: ORS 4000 Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A2666T
Affected products: ORS 4000 Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A2666
Affected products: ORS 4000 Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22014A
Affected products: OES Pediatric Urology Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A37004A
Affected products: OES 4000 Hysteroscopy Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A4741
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22041T
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22042A
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22043A
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22040A
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: WA22017A
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22041A
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22042T
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: WA22017T
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22040T
Affected products: OES Pro Urology Resection Sheaths; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: A22043T
The hazard
Olympus has identified complaints related to the ceramic tip of the resection/inner sheath breaking. Olympus is highlighting the importance of strictly adhering to the 'inspection and testing' and 'caution' sections in the IFU for the resection/inner sheath, and the 'inspection before each use' section in the resectoscope system manual.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)