Device product
EVIS EXERA III Gastrointestinal Videoscope
Z-0288-2024
Product summary
- Event
- Event 93212
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1687 units
- Official record key
device-enforcement:Z-0288-2024
Official wording
Reason: Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Code information: Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.