MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES
Received Feb 23, 2005
Report 2430952-2005-00010 · MDR key 575555
Device
Generic name
Endoscopic Instrument
Manufacturer
Bowa Electronic Zubehor Fur ElectrochiruModel number
600-290Catalog number
*
Lot number
NA
Product problems
- Break
- Detachment Of Device Component
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE SURGEON REPORTED THE CABLE IS BROKEN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED IN SEPTEMBER 2004 FROM THE REPORTER. THE CUSTOMER REPORTED THAT THE MONOPOLAR CABLE HAD BROKEN. NO PATIENT INJURY WAS REPORTED. THE CAUTERY CORD SEPARATED FROM THE CONNECTOR. THERE WAS AN APPEARANCE OF STATIC ON THE SCREEN BEFORE HAND. WHEN THE SURGEON STARTED USING THE MONOPOLAR DEVICE, THE CORD WAS FINE THEN THE CORD SNAPPED IN HALF. NO PATIENT INJURY OR USER INJURY WAS REPORTED. THERE IS A POTENTIAL FOR AN ELECTRICAL SHOCK TO THE USER WHEN DISCONNECTING CORD FROM THE POWER SUPPLY. A SPARK OR FIRE IN AN OPERATING ROOM HAS THE POTENTIAL TO CAUSE A SERIOUS INJURY SUCH AS A BURN. IN ORDER TO INSURE PT SAFETY AORN STANDARDS RECOMMEND THAT DURING LAPAROSCOPIC PROCEDURES ONE SHOULD: EXAMINE ALL ELECTRODES FOR IMPAIRED INSULATION BEFORE USE, ENSURE PROPER CONNECTION OR EQUIPMENT, ENSURE THAT THE ACTIVE ELECTRODE IS NOT ACTIVATED UNTIL IT IS IN CLOSE PROXIMITY TO THE TISSUE, AND USE THE LOWEST POWER SETTING THAT ACHIEVES THE DESIRED RESULT.