ASSI FIBER OPTIC RETRACTOR

Additional Manufacturer Narrative

ON MAY 31, USER FACILITY EXPLAINED TO IMPORTER THAT THE PATIENT WAS BURNED BECAUSE THE HOSPITAL OR PERSONNEL LAID THE ASSEMBLED BREAST RETRACTOR, ADAPTER, AND LIGHT CORD ON THE PATIENT'S ABDOMEN. THE BREAST RETRACTOR WAS NO LONGER AVAILABLE FOR INVESTIGATION. IMPORTER REQUESTED ADDITIONAL INFORMATION WITH REGARD TO THE BREAST RETRACTOR, SUCH AS LOT NO. AND ORDER NO. IMPORTER ALSO REQUESTED IDENTIFICATION OF THE FIBER OPTIC DEVICES (LIGHT CORD, ADAPTER, AND LIGHT SOURCE) THAT HAD BEEN USED DURING THE PROCEDURE, INCLUDING THE NAME OF THEIR MANUFACTURER(S). TO DATE THIS INFORMATION HAS NOT BEEN PROVIDED BY USER FACILITY, DESPITE FOUR ADDITIONAL ATTEMPTS MADE TO OBTAIN THE INFORMATION REQUESTED. THE BREAST RETRACTOR DOES NOT CONDUCT NOR EMIT HEAT EVEN WHEN CONNECTED TO AN ACTIVE LIGHT SOURCE, THUS ALLOWING OR PERSONNEL TO HOLD AND SAFELY MANIPULATE THE INSTRUMENT DURING SURGICAL PROCEDURES. HOWEVER, THE LIGHT SOURCE DOES GENERATE HEAT AND CAN CAUSE THE ADAPTER CONNECTION TO HEAT UP SUFFICIENTLY TO CAUSE BURNS. A WARNING STATEMENT TO THIS EFFECT IS CONSPICUOUSLY FEATURED IN THE INSTRUCTIONS FOR USE AS WELL AS ON THE DEVICE PACKAGING. IN ADDITION, ROUTINE HOSPITAL PROTOCOL DICTATES NEVER TO PLACE AN INSTRUMENT ON THE PATIENT. NO ISSUES INVOLVING THIS DEVICE HAVE BEEN RECORDED IN THE PAST. NO ADDITIONAL INVESTIGATION IS POSSIBLE SINCE DEVICE WAS NOT RETURNED AND NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING FROM USER FACILITY.

Description of Event or Problem

DURING SURGERY FOR MASTECTOMY WITH RECONSTRUCTION, THE ASSEMBLED BREAST RETRACTOR, ADAPTER, AND LIGHT CORD WERE PLACED ON THE PATIENT'S ABDOMEN BY OR PERSONNEL. THE LIGHT CORD WAS CONNECTED TO AN ACTIVE LIGHT SOURCE AT THE TIME. THE PATIENT SUFFERED A SUPERFICIAL PARTIAL THICKNESS BURN ON LEFT UPPER ABDOMEN.