Endoscopic Electrosurgical Handpiece
- Recalling firm
- Olympus (NZ) Ltd
- Product
- Endoscopic electrosurgical handpiece. [Device]. Model: Model: KD-V411M & KD-V431M - CleverCut 3V Single Use 3-Lumen Sphincterotome V; Model: KD-VC411Q & KD-VC431Q - CleverCut 3V Single Use Sphincterotome V (Distal Wireguided) with C-Channel. Affected: Multiple lots; Multiple lots. Also covers: Andotherapy device, active, single-use
- Reason
- The manufacturer has observed an increase in complaints regarding wire deformation in the CleverCut 3V Sphincterotome devices. Preliminary investigations showed that units manufactured with a thermoforming process, which involves heating the assembly, so the device tip keeps the curved stylet's shape, are less likely to have an incorrect cutting wire orientation. Devices which did not undergo thermoforming could deform and lose performance. As a result, the manufacturer is removing lots where the devices may not have been manufactured with the thermoforming process.
- 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/7cb514f7-463e-4fc5-93e5-fbe7212bec27