MalfunctionGFD
ZIMMER AIR DERMATOME
Received Apr 17, 2026
Report 0001526350-2026-00461 · MDR key 24909894
Device
Product problems
- Failure to Cut
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. G2: FOREIGN, EVENT OCCURRED IN (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE UNIT HANDPIECE CUTS TOO DEEP. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DUE DILIGENCE IS IN PROCESS, AND THERE¿S NO ADDITIONAL INFORMATION AVAILABLE.