BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE 10 FEET

    MDR report key: 4173477 · Received September 9, 2014

    Report

    Report Number
    2523190-2014-00059
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    July 18, 2014
    Report Date
    August 19, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GEI
    PMA / PMN Number
    K932456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    MEDWATCH # (B)(4) REPORTS THAT A JARIT MONOPOLAR CORD CAUGHT ON FIRE. IT WAS INSERTED INTO A FORCE FX ELECTROSURGICAL DEVICE (COVIDIEN/VALLEYLAB; MODEL# FORCE FX-CS; SERIAL# (B)(4)). THE SETTING WERE 50 CUT, 70 COAG. CAUTERY HAD BEEN USED FOR 2-3 MINUTES. THE SURGICAL TECHNICIAN SAW FLAMES COMING FROM THE "BANANA CORD" END THAT WAS PLUGGED INTO ELECTROSURGICAL DEVICE CORD. THE POWER SWITCH WAS TURNED OFF, AND WE PULLED THE PLUG OUT FROM THE ELECTROSURGICAL DEVICE. THE END OF THE CORD HAD BEEN SEVERED FROM THE FIRE. THERE WAS NO HARM TO THE PT OR STAFF. ON (B)(6) 2014, CUSTOMER REPORTS "THE FIRE WAS EXTINGUISHED BY THE NURSE TURNING OFF THE MACHINE, AND DISCONNECTING THE CORD FROM THE GENERATOR. THE FIRE WENT OUT BY ITSELF, BUT THE GENERATOR AND CORD WERE INSPECTED TO MAKE SURE THE FIRE WAS COMPLETELY OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555091 MONOPOLAR CABLE 10 FEET ELECTROSURGICAL COAGULATION GEI INTEGRA YORK, PA INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 SERIAL# (B)(4)| COVIDIEN/VALLEYLAB, MODE# FORCE FX-CS