BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CABLE, HF, UNIPOLAR

    MDR report key: 4433996 · Received January 14, 2015

    Report

    Report Number
    1418479-2014-00054
    Event Type
    Injury
    Date Received
    January 14, 2015
    Report Date
    December 29, 2014
    Manufacturer
    BOWA ELECTRONICS
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WILL NOT BE PERFORMED BY RWMIC AS DEVICE IN QUESTIONED IS MANUFACTURED BY BOWA. DEVICE IN QUESTION IS IN TRANSIT TO THE RWMIC FACILITY AND THEN WILL BE FORWARDED TO MFR FOR INVESTIGATION. RWMIC SALES REP MENTIONED CABLE DOES NOT RESEMBLE A CABLE SOLD BY RWMIC. CABLE HAS "OMS" ENDS INDICATING 3RD PARTY REPAIR HAS BEEN PERFORMED. RWMIC HAS CONTACTED FACILITY AND REQUESTED ADDITIONAL INFO CONCERNING THE EVENT AND PT INVOLVEMENT/INFO, NO RESPONSE AS OF (B)(6)2015. RICHARD WOLF MEDICAL INSTRUMENTS CORP CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFO, WE WILL PROVIDE MFR WITH INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTATION CORP (RWMIC) THAT THERE WAS A FIRE IN THE OPERATING ROOM WHILE USING AN UNIPOLAR CABLE ((B)(4)). NO INJURY TO PT OR STAFF MEMBER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33278 CABLE, HF, UNIPOLAR HIGH FREQUENCY CABLE GEI BOWA ELECTRONICS 8106.033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other