BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 2132323 · Received June 11, 2011

    Report

    Report Number
    1811755-2011-02146
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZI
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE CORD WAS RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE CORD CAUSED AN ATTACHED DEVICE TO RUN-ON DURING AN ON-SITE MAINTENANCE VISIT AT THE ACCOUNT. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS HANDPIECE CORD DZI STRYKER INSTRUMENTS KALAMAZOO 09334

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK