MalfunctionGFD
HANDPIECE, ELECTRIC DERMATOME
Received May 5, 2026 · Event occurred Apr 9, 2026
Report 0001526350-2026-00537 · MDR key 25080650
Device
Product problems
- Unstable
- Intermittent Loss of Power
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE MOTOR DOES NOT OPERATE CONTINUOUSLY; IT ONLY RUNS AT FULL SPEED. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DUE DILIGENCE IS IN PROCESS.
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 FINLAND.