BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOC158/75 FIBER OPTIC LIGHT CABLE 3.5MM X 2300MM

    MDR report key: 18658341 · Received February 7, 2024

    Report

    Report Number
    18658341
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    December 6, 2023
    Report Date
    January 29, 2024
    Manufacturer
    ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. (ASSI)
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE LIGHT CARRIER CORD FOR THE FACELIFT RETRACTOR, WITHOUT THE HANDHELD PIECE 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. THE FACELIFT RETRACTOR AND CORD DO NOT GIVE ANY WARNINGS WHEN OVERHEATED OR WHEN THE DEVICE HAS NOT BEEN IN USE FOR A SPECIFIED PERIOD OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193513 FOC158/75 FIBER OPTIC LIGHT CABLE 3.5MM X 2300MM LIGHT SOURCE, FIBEROPTIC, ROUTINE FCW ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. (ASSI) FOC158/75

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male