BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE FIBER OPTIC CABLE, 10FT, PINK

    MDR report key: 7755286 · Received August 6, 2018

    Report

    Report Number
    3011394215-2018-00005
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    INVUITY, INC
    Product Code
    FST
    UDI-DI
    00816728020202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING EVALUATION, IT WAS NOTED THAT BROKEN FIBERS WERE PRESENT THROUGHOUT THE CABLE. ADDITIONALLY, THE CABLE EXHIBITED A CONCENTRATED NUMBER OF BROKEN FIBERS WHICH INDICATES MISHANDLING OF THE CABLE. THE CONCENTRATION OF BROKEN FIBERS LED TO AN ELEVATED TEMPERATURE. INVUITY'S IFU CLEARLY STATES TO HANDLE THE CABLES WITH CARE AND NOT TO COIL THE CABLES TIGHTER THAN SIX (6) INCHES.

    Description of Event or Problem · 1

    DURING A HIP REPLACEMENT PROCEDURE, IT WAS OBSERVED THAT THE DRAPE HAD A BURN MARK WHERE THE FIBER OPTIC CABLE HAD BEEN RESTING UPON IT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592443 SINGLE FIBER OPTIC CABLE, 10FT, PINK SINGLE FIBER OPTIC CABLE, 10FT, PINK FST INVUITY, INC FC1SP UNKNOWN 00816728020202

    Patients

    Seq Age Sex Outcome Treatment
    1