BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE/VALLEYLAB/ERBE INT. HF MONOPOLAR CABLE

    MDR report key: 2430789 · Received January 5, 2012

    Report

    Report Number
    1418479-2011-00024
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Report Date
    January 4, 2012
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K982677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RETURN AUTHORIZATION NUMBER WAS PROVIDED TO FACILITY. A COMPLETE INVESTIGATION WILL BE PERFORMED WHEN THE DEVICE IS RECEIVED AND EVALUATED. PT INFO, DATE INCIDENT OCCURRED, DEVICE LOT NUMBER, ETC. HAS NOT BEEN PROVIDED BY FACILITY YET. RWMIC WILL INCLUDE THIS INFO IN OUR FOLLOW-UP IF/WHEN RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, RICHARD WOLF MEDICAL INSTRUMENTS CORP. RECEIVED A VERBAL COMPLAINT FOR 8106.033 BOVIE CABLE. FACILITY REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE THE BOVIE CABLE TURNED RED AND APPEARED TO BE HOT, THEN THE CABLE BROKE. A PT WAS ON THE TABLE WHEN THIS OCCURRED, PT DID NOT INCUR ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE/VALLEYLAB/ERBE INT. HF MONOPOLAR CABLE HF MONOPOLAR CABLE GEI RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8106.033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other