BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK BUTTON (BOX OF 5)

    MDR report key: 5686566 · Received May 27, 2016

    Report

    Report Number
    2951238-2016-00467
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    May 18, 2016
    Report Date
    May 27, 2016
    Manufacturer
    GYRUS AMCI, INC.
    Product Code
    FAS
    PMA / PMN Number
    PK093181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT THIS TYPE OF OCCURRENCE. "DO NOT PLACE ACTIVE ACCESSORIES NEAR OR IN CONTACT WITH FLAMMABLE MATERIALS (SUCH AS GAUZE OR SURGICAL DRAPES). ELECTROSURGICAL ACCESSORIES WHICH ARE ACTIVATED OR HOT FROM USE CAN CAUSE A FIRE. SHOULD THE DEVICE BECOME DEFORMED OR DAMAGED IN ANYWAY, IT SHOULD BE REPLACED IMMEDIATELY AS CONTINUED USE MAY RESULT IN UNPREDICTABLE OPERATION OR DEVICE FAILURE."

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC CYSTOSCOPY TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE DEVICE BEGAN TO SMOKE AND BURN WHILE INSIDE THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING A DIFFERENT BUT SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339279 PK BUTTON (BOX OF 5) ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL FAS GYRUS AMCI, INC. 786500 U1512119

    Patients

    Seq Age Sex Outcome Treatment
    1