BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 LT WT FIBER OPT SURG HELMET

    MDR report key: 2990220 · Received March 5, 2013

    Report

    Report Number
    0001811755-2013-00445
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FXZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INSTRUCTIONS FOR USE, THE ELECTRICAL OUTPUT OF THE T4/T5 POWER PACK IS 6.0 VOLT AND THE ELECTRICAL OUTPUT FOR THE FLYTE POWER PACK IS 7.2-7.4 VOLT, WHICH WOULD NOT BE ENOUGH VOLTAGE TO CAUSE A SERIOUS INJURY DUE TO SHOCK. ACCORDING TO THE UL 60601-1, THIS IS WELL UNDER THE MAXIMUM VOLTAGE FOR A HEALTHY INDIVIDUAL TO HAVE ACCESSIBILITY TO RESULTING IN INJURY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT. THE BATTERY PACK IS NOT IN THE STERILE FIELD AND IS ONLY HANDLED BY THE USER AND THEREFORE WILL NOT HAVE CONTACT WITH A PATIENT.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED. FAILURE ANALYSIS IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE EVALUATION, IT WAS CONFIRMED THAT THE REPORTED BARE WIRES WERE FIBER OPTIC WIRES, AND NOT ELECTRICAL WIRES. FIBER OPTIC WIRES DO NOT POSE A SAFETY RISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE FIBER OPTIC LIGHT CABLE WAS SPLIT AND EXPOSING WIRES. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE FIBER OPTIC LIGHT CABLE WAS SPLIT AND EXPOSING WIRES. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE FIBER OPTIC LIGHT CABLE WAS SPLIT AND EXPOSING WIRES. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93535 T5 LT WT FIBER OPT SURG HELMET HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1