HF-MONOPOLAR CONNECTING CABLE
Received May 25, 2010 · Event occurred Apr 29, 2010
Report 9611102-2010-00001 · MDR key 1701633
Device
Generic name
Hf-monopolar Connecting Cable
Manufacturer
Richard Wolf GmbhModel number
815,034Catalog number
815,034
Lot number
4/99
Product problems
- Thermal Decomposition of Device
Patient
71 YR
- Perforation
Narrative
Description of Event or Problem
DURING AN ENDOSCOPICAL TRANSURETHRAL PROSTATE SURGERY THE HF-CABLE BURNED NEAR FROM THE INSTRUMENT PLUG. BECAUSE OF THIS, THE SURGEON WAS DISTRACTED SO THAT HE PERFORATED THE PT PROSTATE CAPSULE. THIS EVENT OCCURRED IN THE MIDDLE OF THE SURGERY. THE SURGEON USED ANOTHER CABLE AND COULD FINISH THE SURGERY WITHOUT FURTHER PROBLEMS.
Additional Manufacturer Narrative
THE VISUAL INSPECTION SHOWED THAT THE STRAIN RELIEF WAS BROKEN ON BOTH ENDS OF THE CABLE. THE BREAKAGE OF THE WIRES OCCURRED WHEN HIGH CURRENT HEATED THE AREA. BECAUSE OF THE BROKEN WIRES, ARCING OCCURRED. THE CABLE HAS BEEN IN USE SINCE MORE THAN 10 YRS AND WAS WORN OVER THIS LONG PERIOD OF YRS DUE TO REPEATED INSERTION AND REMOVAL OF CABLE FROM THE INSTRUMENTS. WE WILL SEND THE CABLE TO THE SUPPLIER, (B)(4) FOR FURTHER ASSESSMENT. AFTER THE RESPONSE FROM (B)(4) WE WILL SUBMIT A FOLLOW UP.