Device product
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Z-1473-2024
Product summary
- Event
- Event 94171
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-1473-2024
Official wording
Reason: Inadequate reprocessing validation evidence
Code information: UDI: 04048551259788/ All Lots
Distribution pattern: US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.
Derived failure modes
-
Unknown
Inadequate reprocessing validation evidence