BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 6 BATTERY

    MDR report key: 2082558 · Received April 28, 2011

    Report

    Report Number
    1811755-2011-01448
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 31, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KIJ
    PMA / PMN Number
    K972367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY WAS VISUALLY EXAMINED AND THERE WAS NO VISUAL DAMAGE, CONTAMINATION, OR EVIDENCE THAT THE BATTERY WAS TAMPERED WITH. THE BATTERY WAS NOTED TO HAVE A RESIDUE OF FLUID FOUND EXTERNALLY ON THE BOTTOM OF THE BATTERY. THE LEAKING FLUID IS MOST LIKELY ELECTROLYTE FROM THE CELLS, CONFIRMING THE CUSTOMER COMPLAINT. THERE WAS NO EVIDENCE TO SHOW THAT THE BATTERY EXPLODED. THE BATTERY WAS DISASSEMBLED FOR FURTHER INVESTIGATION AND IT WAS DISCOVERED THAT THERE WAS STERILIZATION FLUID AND CORROSION INSIDE THE HOUSING. IN ADDITION, THERE WAS VENTED ELECTROLYTE AND DETERIORATION OF ONE OF THE CELL'S SLEEVES. THE CAUSE OF THE FAILURE WAS FLUID INTRUSION LIKELY DUE TO IMPROPER STERILIZATION. THE DHR FOR THIS LOT INDICATED THE DEVICE PASSED ALL TESTING AND INSPECTIONS AS REQUIRED AT THE TIME OF MANUFACTURE; THERE WERE NO RELEVANT NON-CONFORMANCES, ALERTS, DEVIATIONS, OR REWORK. THERE WERE NO RELEVANT DESIGN/PROCESS CHANGES RELATED TO THIS REPORTED EVENT. THE CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY EXPLODED AND LEAKED ACID DURING A PROCEDURE. THIS RESULTED IN A 5 MIN DELAY. ATTEMPTS ARE BEING MADE TO COLLECT ADD'L INFO FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 6 BATTERY KIJ STRYKER INSTRUMENTS KALAMAZOO 10341

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK