BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 NON STERILE BATTERY

    MDR report key: 3983037 · Received August 6, 2014

    Report

    Report Number
    0001811755-2014-02802
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, THERE IS A LEAK IN THE BATTERY, WAS NOT DUPLICATED, HOWEVER, THE REPORTED EVENT OF CHARGER SAYS ERROR 7, WAS DUPLICATED. THROUGH FUNCTIONAL AND VISUAL EVALUATION, THE BATTERY WAS PLACED ON THE CHARGER AND THE CHARGER DISPLAYED ¿ERROR 7¿. THE BATTERY WAS DISASSEMBLED AND INTERNAL CORROSION AND SIGNS OF FLUID INGRESS WERE DETECTED DUE TO IMPROPER STERILIZATION. DEVICE WAS PLACED IN PARTS RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYSTEM 6 NON STERILE BATTERY IS LEAKING BEFORE THE PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS PERFORMED USING BACK-UP EQUIPMENT. 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 SYSTEM 6 NON STERILE BATTERY IS LEAKING BEFORE THE PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS PERFORMED USING BACK-UP EQUIPMENT. 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
    460877 SYSTEM 6 NON STERILE BATTERY INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 13056

    Patients

    Seq Age Sex Outcome Treatment
    1