CABLE, HF, UNIPOLAR
Received Nov 20, 2013 · Event occurred Oct 1, 2013
Report 1418479-2013-00033 · MDR key 3489672
Device
Generic name
High Frequency Cable
Manufacturer
Bowa ElectronicsModel number
8106.033Catalog number
8106.033
Lot number
844/135
Product problems
- Sparking
Patient
Not reported
- Flashers
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2013, RICHARD WOLF MEDICAL INSTRUMENT CORPORATION (RWMIC) RECEIVED A VERBAL COMPLAINT ON A HIGH FREQUENCY UNIPOLAR CABLE (8106.033). FACILITY REPORTED DEVICE FAILED DURING SURGERY, HOWEVER NO INJURY TO PT OR STAFF OCCURRED. FACILITY WAS CALLED ON (B)(4)2013 TO GO OVER INCIDENT TO DETERMINE IF MDR REPORTABLE. IT WAS AT THIS TIME FACILITY INDICATED THERE WAS A SPARK AND THEN THE CORD BROKE DURING PROCEDURE. SIMILAR DEVICE WAS READILY AVAILABLE FOR USE, NO DELAY IN PROCEDURE AND NO INJURIES TO PT OR STAFF OCCURRED.
Additional Manufacturer Narrative
DEVICE WAS RETURNED TO RWMIC (B)(4) 2013. DESCRIPTION OF EVENT, CABLE ID, SERIAL NUMBER AND PHOTOS OF CABLE WERE SENT TO MANUFACTURER. MANUFACTURER REPORTED, PER GOOGLE TRANSLATE ((B)(6)), DEVICE MANUFACTURED 10/2008 AND REACHED END OF LIFE, TWO YEARS AFTER DEPLOYMENT. DEVICE PURCHASED 11/2009. PER RWMIC ELECTRONICS MANAGER, BROKEN STRANDS IN THE CABLE WILL CAUSE THE CABLE TO ARC/SPARK DURING THE APPLICATION. BROKEN STRANDS CAN BE CAUSED BY NORMAL WEAR AND TEAR, OR PULLING ON THE CORD (CABLE) INSTEAD OF THE BLACK PLUG. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE THE DEVICE OR ADDITIONAL INFO IS RECEIVED, WE WILL PROVIDE FDA WITH FOLLOW-UP INFO.