BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18865128 · Received March 8, 2024

    Report

    Report Number
    2434839-2024-00001
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    December 6, 2023
    Report Date
    March 22, 2024
    Manufacturer
    ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.
    Product Code
    FCW
    UDI-DI
    00841645131946
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747887 FIBER OPTIC LIGHT CABLE 3.5MM X 2300MM; 7.5 FT. FIBER OPTIC LIGHT CABLE FCW ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. 00841645131946

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male