MalfunctionGFD
HANDPIECE, ELECTRIC DERMATOME
Received May 6, 2026
Report 0001526350-2026-00544 · MDR key 25094147
Device
Product problems
- Output below Specifications
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS INCIDENT IS BEING RECORDED UNDER (B)(4). THE DEVICE WILL BE RETURNED FOR ANALYSIS, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY THE UNIT COULD NOT GET THE RPMS WITHIN IN SPECIFICATION. NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE.