InjuryGZI
VECTRA GENISYS
Received Dec 21, 2022 · Event occurred Dec 5, 2022
Report 9616086-2022-00032 · MDR key 16026891
Product problems
- Unintended Electrical Shock
- Unintended Electrical Shock
Patient
Unknown
- Burn(s)
- Electric Shock
- Burn(s)
- Electric Shock
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE UNIT ALLEGEDLY SHOCKED AND CAUSED A BURN TO PATIENT DURING TREATMENT. ENOVIS HAS RECEIVED SUFFICIENT INFORMATION REGARDING THE REPORTED BURN THE DEGREE OF BURN IS UNKNOWN AND MEDICAL INTERVENTION WAS REQUIRED. PATIENT WAS TREATED WITH ANTIBIOTIC CREAM AND A BAND AID. AFTER PERFORMING FUNCTIONAL AND ELECTRICAL TESTING, THE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. THE PRODUCT MET MANUFACTURER SPECIFICATIONS.
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT ALLEGEDLY SHOCKED AND CAUSED A BURN TO PATIENT DURING TREATMENT.