MalfunctionGFD
ZIMMER AIR DERMATOME, COMPLETE
Received May 4, 2026 · Event occurred Apr 8, 2026
Report 0001526350-2026-00529 · MDR key 25071286
Device
Product problems
- Gas/Air Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
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: CANADA.
Description of Event or Problem
IT WAS REPORTED THAT DURING SURGERY, THE UNIT HAD AN AIR LEAK FROM THE HAND HELD DEVICE. THERE WAS NO PATIENT IMPACT A DELAY OF A FEW MINUTES OCCURRED WHILE LOOKING FOR ANOTHER DEVICE. NO ADDITIONAL SKINGRAFT WAS REQUIRED. DUE DILIGENCE IS COMPLETE AS NO FURTHER INFORMATION IS AVAILABLE.