HANDPIECE, ELECTRIC DERMATOME
Received May 13, 2026 · Event occurred Apr 21, 2026
Report 0001526350-2026-00573 · MDR key 25163594
Device
Product problems
- Calibration Problem
- Failure to Shut Off
- Output below Specifications
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT WAS SENT IN FOR YEARLY CALIBRATION. THE HANDPIECE MOTOR WAS WEAK AND POWER OFF AFTER ENGAGING FOR A PERIOD OF ACTIVATION. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
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.