Device product
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
Z-0716-2024
Product summary
- Event
- Event 93613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3001 units
- Official record key
device-enforcement:Z-0716-2024
Official wording
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.
Code information: Lot Number: All units sold prior to 2023
Distribution pattern: US Nationwide. Global Distribution
Derived failure modes
-
Unknown
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.