BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T5 LT WT FIBER OPT SURG HELMET

    MDR report key: 4928496 · Received July 21, 2015

    Report

    Report Number
    0001811755-2015-02639
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 26, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FXZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SCRAPPED BY STRYKER

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY THE TIP OF THE DEVICE CORD OVERHEATED AND MELTED. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY THE TIP OF THE DEVICE CORD OVERHEATED AND MELTED. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471573 T5 LT WT FIBER OPT SURG HELMET HELMET, SURGICAL FXZ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1