Device product
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
Z-1132-2023
Product summary
- Event
- Event 91411
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1132-2023
Official wording
Reason: A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
Code information: UDI: 04953170202315 Serial number 2807443
Distribution pattern: US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
Derived failure modes
-
Microbial contamination
microbial contamination