BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPOLAR CONNECTING CABLE

    MDR report key: 2033007 · Received March 18, 2011

    Report

    Report Number
    1418479-2011-00004
    Event Type
    Death
    Date Received
    March 18, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 18, 2011
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS
    Product Code
    GEI
    PMA / PMN Number
    K983236
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS CURRENT DATE, THE DEVICE IS IN RICHARD WOLF'S POSSESSION. WE ARE IN THE PROCESS OF COMPLETING AN INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BIPOLAR CORD MALFUNCTIONED DURING A DIAGNOSTIC LAPAROSCOPIC CYST PROCEDURE. THE SURGEON USED A NON-WOLF INSTRUMENT TO DISSECT ADHESION AND THE PT'S UTERINE VEIN WAS NICKED. THE WOLF BIPOLAR CORD WAS USED TO CONNECT THE MEGADYNE GENERATOR AND A NON-WOLF SURGICAL INSTRUMENT FOR CAUTERY. THE SURGEON WAS NOT ABLE TO STOP THE BLEEDING. THE END RESULT IS THAT THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR CONNECTING CABLE BIPOLAR CONNECTING CABLE GEI RICHARD WOLF MEDICAL INSTRUMENTS 8108.033 5/01

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death