BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CORD 10' ANGLED 90DEGREES

    MDR report key: 2821935 · Received September 27, 2012

    Report

    Report Number
    1530493-2012-00001
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    July 10, 2012
    Report Date
    September 27, 2012
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K111262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE USER FACILITY (B)(6) HOSPITAL AND CLINIC WOULD NOT RETURN THE DEVICE FOR EVALUATION, DUE TO HOSPITAL POLICY AND LEGAL REASONS. THEY WERE ALSO UNABLE TO PROVIDE THE LOT NUMBER OF THE DEVICE. BUT, THEIR RISK MANAGER (B)(4) WAS ABLE TO PROVIDE PHOTOS OF THE DEVICE, ON (B)(4) 2012. THROUGH VISUAL EXAMINATION OF THE PROVIDED PHOTOS OF THE DEVICE NO CONCLUSIVE DETERMINATION COULD BE MADE. BUT, THE DEVICE DID APPEAR TO BE USED PAST THE RECOMMENDED 20 USES AND STERILIZATION CYCLES, WHICH IS CLEARLY STATED IN THE INSTRUCTIONS FOR USE. THE PURCHASING HISTORY OF (B)(6) HOSPITAL WAS REQUESTED FROM OUR SISTER COMPANY, (B)(6) FORMERLY (B)(6), WHO DISTRIBUTES THIS DEVICE. IT WAS FOUND THAT THIS USER FACILITY HAS BEEN PURCHASING THIS DEVICE SINCE 2008. WITHOUT THE DEVICE TO EVALUATE NO CONCLUSIVE DETERMINATIONS CAN BE MADE.

    Description of Event or Problem · 1

    A MONOPOLAR CORD CAUGHT FIRE DURING A SURGICAL CASE. THE CORD BURNED AND BROKE APART. THE GENERATOR/ESU MACHINE WAS TURNED OFF AND THE FIRE WAS EXTINGUISHED IMMEDIATELY. THE PATIENT WAS ASSESSED AND THERE WAS NO INJURY TO THE PATIENT. NO ONE IN THE OPERATING ROOM WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CORD 10' ANGLED 90DEGREES GEI OLSEN MEDICAL 50-2107 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1