ZIMMER AIR DERMATOME
Received Jun 30, 2026 · Event occurred Jun 4, 2026
Report 0001526350-2026-00750 · MDR key 25664404
Device
Product problems
- Fitting Problem
- Calibration Problem
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- 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: FOREIGN - EVENT OCCURRED IN SINGAPORE.
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT WAS SENT IN FOR ANNUAL CALIBRATION AND MAINTENANCE. THERE WERE SOME DIFFICULTIES CONNECTING THE AIR HOSE TO THE HANDPIECE, MUCH RESISTANCE NEEDED TO CONNECT PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.