Resectoscope Resection Sheaths
- Recalling firm
- Olympus (NZ) Ltd
- Product
- Resectoscope Resection Sheaths. [Device]. Model: RESECTION SHEATH and INNER SHEATH. Affected: Multiple lots
- Reason
- The manufacturer has identified complaints related to the ceramic tip of the resection/inner sheath breaking. There were reports, where the tip fell off during the procedure. In most events, the clinician identified and retrieved the fragment during the procedure. By nature, ceramics are not pliable and may fracture unexpectedly under significant mechanical impact. The manufacturer' investigation revealed that some devices remain in use for prolonged periods and may be subjected to stress over their operational lifetime., The manufacturer is highlighting the importance of strictly adhering...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-12
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/ba6d8521-c5aa-471d-8fc6-84be08c59f8b