BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS BI-DIRECTIONAL FOOTSWITCH

    MDR report key: 2233153 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02623
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 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

    THE FOOTSWITCH WAS RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVAL WILL BE CONDUCTED, AND A F/U REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE FOOT PEDAL WAS DEPRESSED IT STUCK AND WOULD NOT RELEASE DURING A SURGICAL PROCEDURE. THERE WAS NO MEDICAL INTERVENTION AND NO PROCEDURAL DELAY. 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 BI-DIRECTIONAL FOOTSWITCH ERL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK