BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 2160673 · Received June 30, 2011

    Report

    Report Number
    1811755-2011-02331
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZI
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE CORD WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION. IT WAS CONFIRMED THAT THE CORD HAS A DAMAGED END. 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 BY A FIELD SERVICE TECH THAT THE HANDPIECE CORD CAUSED AN ATTACHED DEVICE TO RUN ON ITS OWN DURING AN ON-SITE MAINTENANCE VISIT AT THE ACCOUNT. THIS DID NOT OCCUR DURING A SURGICAL PROCEDURE. THERE WAS NO PT 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 10252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK