12' DISP. BIPOLAR FORCEPS CORD (10/BX)
Received Jan 30, 2017 · Event occurred Dec 21, 2016
Report 3003898360-2017-00054 · MDR key 6286115
Device
Product problems
- Sparking
- Sparking
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE ALLEGED DEFECT. AT THIS TIME DUE THE SAMPLE IS NOT AVAILABLE IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE PRODUCT SAMPLE IS NOT AVAILABLE TO PERFORM A PROPER INVESTIGATION AND DETERMINATE THE ROOT CAUSE. IF THE ALLEGED DEFECT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.
Description of Event or Problem
DURING A CARPAL TUNNEL REPAIR THE BIPOLAR FORCEPS CORD SHOWED SPARKS BETWEEN THE FORCEP AND THE PLUG INTO THE CORD. IT BURNED THE END OF THE CORD AND THE END FOR THE FORCEP BY THE POST. THERE WAS NO PATIENT INJURY.
Additional Manufacturer Narrative
(B)(4). THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
DURING A CARPAL TUNNEL REPAIR THE BIPOLAR FORCEPS CORD SHOWED SPARKS BETWEEN THE FORCEP AND THE PLUG INTO THE CORD. IT BURNED THE END OF THE CORD AND THE END FOR THE FORCEP BY THE POST. THERE WAS NO PATIENT INJURY.