BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER OPTIC LIGHT CABLE

    MDR report key: 18011499 · Received October 26, 2023

    Report

    Report Number
    18011499
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    August 31, 2023
    Report Date
    September 29, 2023
    Manufacturer
    GULF FIBEROPTICS, INC.
    Product Code
    FDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DR. NEED TO ADJUST THE BOTTOM BLADE OF THE RETRACTOR & HAD TO REMOVE THE LIGHT SOURCE TO DO SO. THE DISPOSABLE LIGHT SOURCE IS MALLEABLE & WAS BENT AT 90 DEGREES TO FIT INTO THE RETRACTOR BLADE. WHEN HE REMOVED THE LIGHT SOURCE, HE PLACED IT ON TOP OF THE PATIENT WITH THE LIGHT SOURCE STICKING UP IN THE AIR, NOT DOWN ON THE PATIENT. I NOTICED THE RETRACTOR "SPARK" MULTIPLE TIMES AS TO WHICH I NOTIFIED DRS THAT THE LIGHT SOURCE WAS CATCHING ON FIRE. I ASKED MY NURSE, TO RUN AND GRAB STERILE WATER. MY ORIENTEE TOOK A BLUE TOWEL & DRENCHED IT IN SALINE TO PUT UP ON THE FIELD IN THE MEANTIME. AS WE WERE WAITING FOR THE WATER, THE SPARKING STOPPED BUT THEN BLACK SMOKE STARTED TO ARISE FROM THE LIGHT SOURCE WITH AN "ELECTRICAL" SMELL. IT EVENTUALLY STOPPED & WE DIDN'T HAVE TO DUMP WATER ONTO THE FIELD. WE CONFIRMED WITH THE REPS THAT THE LIGHT SOURCE WAS NOT AT 100% & THEY CONFIRMED IT WAS AT 70%. DR. THEN CONFIRMED THAT THERE WAS A PIECE OF TISSUE ON THE TIP OF THE LIGHT SOURCE. WE REMOVED BOTH LIGHT SOURCE BLADES AND TURNED THE LIGHT SOURCE OFF FOR A FEW MINUTES AND THEN RETURNED USING THEM. AS WE MOVED DOWN TO THE NEXT LEVEL, THE SAME THING HAPPENED WITH THE LIGHT SOURCE BLADE BUT THIS TIME THERE WERE NO "SPARKS" ONLY BLACK SMOKE COMING FROM THE LIGHT SOURCE. RN ASKED THE REPS IF THIS HAS HAPPENED BEFORE & THEY SEEMED UNSURE. RETRACTOR BLADES COME FROM ALPHATEC COMPANY AS LOANERS. FIBER OPTIC LIGHT CORD IS DISPOSABLE LAWSON # 690873. LIGHT SOURCE USED WAS LUXTEC MLX CE 33851.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674048 FIBER OPTIC LIGHT CABLE RETRACTOR, FIBEROPTIC FDG GULF FIBEROPTICS, INC. 4.6MM BUNDLE DIAMETER, 10 LENGTH, BIFURCATED CABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA Female