Recall MonitorHealth Products
Olympus Resection and Inner Sheaths
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: Olympus Resection and Inner Sheaths
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| OES Pro Hysteroscopy Sheaths | More than 10 numbers, contact manufacturer. | A42011A |
| OES 4000 Urology Resectoscope System | More than 10 numbers, contact manufacturer. | A2660T |
| ORS 4000 Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A2641 |
| ORS 4000 Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A2660 |
| ORS 4000 Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A2642 |
| ORS 4000 Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22014T |
| ORS 4000 Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A2666T |
| ORS 4000 Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A2666 |
| ORS 4000 Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22014A |
| OES Pediatric Urology Sheaths | More than 10 numbers, contact manufacturer. | A37004A |
| OES 4000 Hysteroscopy Sheaths | More than 10 numbers, contact manufacturer. | A4741 |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22041T |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22042A |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22043A |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22040A |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | WA22017A |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22041A |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22042T |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | WA22017T |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22040T |
| OES Pro Urology Resection Sheaths | More than 10 numbers, contact manufacturer. | A22043T |
Issue
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.