Olympus - Sheaths Laser Sidefire
- Recalling firm
- Olympus (NZ) Ltd
- Product
- Olympus - Sheaths Laser Sidefire. [Device]. Model: SHEATH LASER SIDEFIRE OUTER 22.5Fr. Affected: All serial numbers
- Reason
- In October 2024, Olympus issued a Product Correction in relation to the Cystoscope Outer sheath, 22.5 Fr (Medsafe Ref #33877). The Product Correction Notice instructed users that the Cystoscope Outer sheath should not be used with a GreenLight Laser for BPH therapy until further notice. The manufacturer has received reports about a Cystoscope Outer sheath damaged tip during use of a laser probe. The manufacturer conducted additional testing, which indicated further regulatory actions would be required in order to state compatibility of the cystoscopy sheath with GreenLight laser fibres....
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-13
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/8bf39a91-3a65-4136-952c-226b5e2e8dfd