Device product
Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN
Z-0458-2021
Product summary
- Event
- Event 86596
- Status
- Terminated
- Classification
- Class III
- Quantity
- 293 units:248 units (USA); 45 units OUS
- Official record key
device-enforcement:Z-0458-2021
Official wording
Reason: Potential for cleaning solution intrusion into endoscope
Code information: Distributed from May 23, 2017 to June 30, 2020
Distribution pattern: Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates
Derived failure modes
-
Unknown
Potential for cleaning solution intrusion into endoscope