FIBER OPTIC LIGHT CABLE 3.5MM X 2300MM; 7.5 FT.

Additional Manufacturer Narrative

THE USER FACILITY HAS BEEN REPEATEDLY CONTACTED TO REQUEST RETURN OF THE DEVICE MENTIONED IN THE REPORT AS WELL AS ADDITIONAL INFORMATION WITH REGARD TO USE OF THE DEVICE AND THE PROCEDURE BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED NOR HAS ADDITIONAL INFORMATION BEEN PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

PER USER FACILITY REPORT, DURING AN ELECTIVE FACELIFT AND BILATERAL REMOVAL OF EXCESSIVE TISSUE FROM UNDERNEATH EYES, THE LIGHT CORD FOR THE FACELIFT RETRACTOR -WITHOUT THE HANDHELD RETRACTOR ATTACHED- FELL FROM THE MAYO STAND WHILE THE LIGHT WAS STILL ON 100%. THE CORD FELL ONTO THE DRAPES OVER THE PATIENT'S ABDOMEN RESULTING IN A 1 MM BURN HOLE IN THE DRAPE. THE PATIENT'S SKIN WAS NOT BURNED AND THERE WAS NO INJURY AS A RESULT.

Additional Manufacturer Narrative

ADDITIONAL ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION WITH REGARD TO THE PROCEDURE, ITS OUTCOME, THE LIGHT SOURCE AND THE POWER SETTING AS WELL AS THE LOT# OF THE DEVICE, BUT NO INFORMATION HAS BEEN FORTHCOMING. THE USER FACILITY WAS NOT ABLE TO IDENTIFY AND RETURN THE LIGHT CORD SINCE IT WAS PUT BACK IN USE FOLLOWING THE EVENT. IT HAS BEEN IN USE AT THE FACILITY FOR OVER THREE MONTHS SINCE THE INCIDENT OCCURRED. THE FACILITY HAS INDICATED THAT MULTIPLE LIGHT CABLES OF THIS TYPE ARE CURRENTLY IN USE AND THAT NO RECORDS OF REPAIRS EXIST, THUS INDICATING THAT THE LIGHT CORD INVOLVED IN THE INCIDENT IS FUNCTIONING CORRECTLY. COMPLAINT FILES WERE CHECKED WITH REGARD TO THIS MODEL OF FIBER OPTIC LIGHT CABLE. THE USER FACILITY IN QUESTION HAS BEEN PURCHASING THESE FIBER OPTIC LIGHT CABLES SINCE 2015 WITHOUT INCIDENT. NO COMPLAINTS HAVE BEEN RECEIVED REGARDING THE DEVICE, NEITHER FROM THE USER FACILITY IN QUESTION NOR FROM ANY OTHER CUSTOMER, OTHER THAN MEDWATCH REPORT 2100090000-2024-8002 THAT TRIGGERED THE CURRENT INVESTIGATION. IN ACCORDANCE WITH THE EVENT DESCRIPTION, THE RETRACTOR WAS REMOVED FROM THE CABLE PRIOR TO THE EVENT. IT FOLLOWS THAT OR PERSONNEL WAS FINISHED USING THE RETRACTOR AND THE CABLE, BUT FAILED TO TURN OFF THE LIGHT SOURCE, CAUSING THE LIGHT CABLE CONNECTOR TO HEAT UP UNNECESSARILY. IN ADDITION, THE CABLE WAS NOT ADEQUATELY SECURED AND FELL ON THE DRAPE COVERING THE PATIENT. THE DEVICE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNING WITH REGARD TO POTENTIAL HEATING OF THE LIGHT CABLE CONNECTOR DURING USE: "IN COMBINATION WITH HIGH PERFORMANCE LIGHT SOURCES, THE LIGHT CABLE CONNECTOR WHICH CONNECTS TO THE RETRACTOR CAN HEAT UP CONSIDERABLY AND MAY CAUSE BURNS TO THE PATIENT'S OR USER'S SKIN." THIS WARNING WAS DISREGARDED. WE CONCLUDE THAT THE INCIDENT WAS DUE TO USER ERROR.