Device product
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
Z-2203-2019
Product summary
- Event
- Event 83323
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22204
- Official record key
device-enforcement:Z-2203-2019
Official wording
Reason: Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.
Code information: KIT NUMBERS: DYK1002DBDE, DYK1002DBSE, DYK1002DCB, and DYK1002SBC. LOT NUMBERS: GM10, GJ25, HA05, and HA20
Distribution pattern: US Nationwide distribution in the states of AL, AR, CA, CO, DC, FL, GA, IA, IL, IN, KY, LA, MO, NC, NH, NJ, NM, NY, NV, OH, OK, PA, RI, TN, TX, UT, WV, and WY
Derived failure modes
-
Unknown
Potential risk of brush detachment during cleaning. If brush detachment is not identified, there is the potential for the brush to be left within the scope.