BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VULCAN GENERATOR, CE MARK

    MDR report key: 5031110 · Received August 26, 2015

    Report

    Report Number
    1643264-2015-00128
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GEI
    PMA / PMN Number
    K991140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT OF RF FAILURE WAS CONFIRMED. UNIT FAILED FUNCTIONAL TESTING WITH RF BOARD DISABLED ERROR. CAUSE OF ERROR IS A DEFECTIVE RF BOARD PN: 1180215 WITH DATE CODE/SERIAL NUMBER: (B)(4). UNIT PASSED FUNCTIONAL TESTING WITH A KNOWN GOOD RF BOARD INSTALLED. UNIT REQUIRES NON WARRANTY SERVICE AND REPAIR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE USING VULCAN GENERATOR, CE MARK IT WAS FOUND THAT THE DEVICE HAD TOO LOW IMPEDANCE AND HAD NO FUNCTIONALITY. IT IS UNKNOWN IF THERE WAS A PROCEDURAL DELAY. THERE WAS NO BACK UP DEVICE AVAILABLE. THIS INCIDENT DID NOT RESULT IN ANY PATIENT INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566402 VULCAN GENERATOR, CE MARK ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SMITH & NEPHEW, INC. ZL3634

    Patients

    Seq Age Sex Outcome Treatment
    1