ELECTRIC DERMATOME SYSTEM
Received May 11, 2026 · Event occurred Apr 8, 2026
Report 0001526350-2026-00558 · MDR key 25136397
Device
Product problems
- Material Frayed
- Failure to Power Up
- Output below Specifications
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 SOUTH AFRICA.
Description of Event or Problem
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DERMATOME DID NOT SWITCH ON, WHEN IT DOES IT IS VERY SLOW AND THE ELECTRICAL CABLES ARE EXPOSED. 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.