BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS UNIDIRECTIONAL FOOTSWITCH

    MDR report key: 4113725 · Received September 24, 2014

    Report

    Report Number
    0001811755-2014-03345
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: THE REPORTED EVENT WAS NOT DUPLICATED AND NO FAILURES WERE CONFIRMED DURING THE MANUFACTURER DEVICE EVALUATION. THE DEVICE HAS BEEN DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE WAS STICKING, RESULTING IN RUN ON. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE DEVICE. NO CLINICALLY RELEVANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE WAS STICKING, RESULTING IN RUN ON. HOWEVER, THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE DEVICE. NO CLINICALLY RELEVANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595466 TPS UNIDIRECTIONAL FOOTSWITCH TPS UNIDIRECTIONAL FOOTSWITCH ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1