Recall Z-0716-2024 · GEX Powered Laser Surgical Instrument
Olympus Corporation of the Americas
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
| Date | Jan 12, 2024 (initiated Dec 4, 2023) |
| Status | Open, Classified |
| Reason | The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination. |
| Root cause | Under Investigation by firm |
| Action | An URGENT: MEDICAL DEVICE REMOVAL notification letter dated 12/4/23 was sent to customers. Actions to be taken by the end user: Our records indicate that your facility has received one or more affected units. Olympus requests you to take the following actions: 1. Examine your inventory and quarantine any devices with the lot number specified above. 2. Please contact Olympus customer service representative at 1-800-848-9024, option 2, with the quantity and model of affected devices. Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will iss |
| Quantity | 3001 units |
| Distribution | US Nationwide. Global Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183647 | SOLTIVE Laser System(SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVELaser Fibers, and Acce Olympus Surgical Technologies America, Aug 9, 2019 |