BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE

    MDR report key: 5031047 · Received August 26, 2015

    Report

    Report Number
    0001811755-2015-03124
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY THAT THE HANDPIECE RUNS ON OWN WHEN THE BATTERY WAS INSERTED. THERE WAS NO ASSOCIATED PROCEDURE. 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
    565118 SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT KIJ STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1