BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR CABLE

    MDR report key: 4657778 · Received March 31, 2015

    Report

    Report Number
    1418479-2015-00007
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Report Date
    March 12, 2015
    Manufacturer
    ERBE GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS NOT BEEN COMPLETED, ACTUAL DEVICE WAS DISCARDED WITH NO PHOTOS TAKEN. A REQUEST FOR ADDITIONAL INFO HAS BEEN SUBMITTED TO FACILITY, NO RESPONSE AS OF 03/30/2015. RICHARD WOLF MEDICAL INSTRUMENTS CORP CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFO, WE WILL PROVIDE MFR WITH FOLLOW-UP INFO.

    Description of Event or Problem · 1

    RICHARD WOLF MEDICAL INSTRUMENT CORP (RWMIC) WAS NOTIFIED BY ONE OF ITS SALES REPRESENTATIVES THAT DURING A PROCEDURE, THE DEVICE IN QUESTION SPARKED AND/OR STARTED ON FIRE. NO INJURY TO PT OR STAFF WAS REPORTED. CABLE DISCARDED AND NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210951 BIPOLAR CABLE BIPOLAR CABLE GEI ERBE GMBH 8108.232

    Patients

    Seq Age Sex Outcome Treatment
    1