MalfunctionGFD
ZIMMER AIR DERMATOME
Received Jun 25, 2026
Report 0001526350-2026-00739 · MDR key 25627971
Device
Product problems
- Failure to Cut
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT WAS CUTTING UNEVEN. THERE IS NO INFORMATION PROVIDED REGARDING THE TIMING OF THE EVENT OR IF THERE WAS ANY PATIENT INVOLVEMENT/HARM THAT MAY HAVE OCCURRED. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.
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: CANADA.