BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLIFE LARGE ASPTC HOUSING

    MDR report key: 3904897 · Received July 1, 2014

    Report

    Report Number
    0001811755-2014-02346
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THROUGH SERVICE, HOUSING FRACTURED AND DISASSEMBLED, WAS CONFIRMED. THE ENGINEERING TECHNICIAN OBSERVED THAT THE TOP HOUSING WAS SEPARATED FROM THE LOWER HOUSING, ACCORDING TO RISK DOCUMENTATION AND CASES WITH A SIMILAR REPORTED EVENT, POTENTIAL CAUSES FOR A CRACKED HOUSING INCLUDE EXCESSIVE AUTOCLAVE EXPOSURE, EXPOSURE TO HIGH PH CLEANERS, CLEANING SOLVENTS, OR IMPACT SUCH AS BEING DROPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMARTLIFE LARGE ASEPTIC BATTERY HOUSING DISASSEMBLED AFTER THE STERILIZATION PROCEDURE AT USER FACILITY. THE HOUSING FRACTURED AND THE TOP HOUSING WAS DETACHED FROM THE LOWER HOUSING. NO ASSOCIATED PROCEDURE, 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 THE SMARTLIFE LARGE ASEPTIC BATTERY HOUSING DISASSEMBLED AFTER THE STERILIZATION PROCEDURE AT USER FACILITY. THE HOUSING FRACTURED AND THE TOP HOUSING WAS DETACHED FROM THE LOWER HOUSING. 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
    385065 SMARTLIFE LARGE ASPTC HOUSING INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 13168

    Patients

    Seq Age Sex Outcome Treatment
    1