BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE SABER HANDSWITCH

    MDR report key: 2140411 · Received June 17, 2011

    Report

    Report Number
    1811755-2011-02182
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 20, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DRILL WAS RETURNED TO THE MANUFACTURER FOR PREVENTATIVE MAINTENANCE PURPOSES. DURING THE MAINTENANCE PROCESS, THE SERVICE HANDSWITCH WAS ATTACHED, WHICH CAUSED THE DRILL TO UNINTENTIONALLY ACTIVATE. THE HANDSWITCH WAS REMOVED AND THE DRILL PERFORMED ACCORDING TO SPECIFICATIONS. THE HANDSWITCH COULD NOT BE REPAIRED AND WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER, THE HANDSWITCH CAUSED A DEVICE TO OPERATE WHEN THE TRIGGER WAS NOT ACTIVATED. THIS EVENT DID NOT OCCUR IN A SURGICAL ENVIRONMENT, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE SABER HANDSWITCH ERL STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK