BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR CORD

    MDR report key: 1728924 · Received June 10, 2010

    Report

    Report Number
    1530493-2010-00002
    Event Type
    Other
    Date Received
    June 10, 2010
    Date of Event
    May 11, 2010
    Report Date
    June 9, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K971540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END-USER REPORTED TO OLSEN MEDICAL, THE MONOPOLAR CORD SPARKED AND CAUGHT A SURGICAL DRAPE ON FIRE. THE END-USER ALSO REPORTED THEY HAD USED THE DEVICE BEYOND ITS WARRANTY AND THE LOT NUMBER HAD BEEN REMOVED. THIS WAS ALSO EVIDENCED BY VISUAL EXAMINATION OF THE DEVICE UPON RETURN.

    Description of Event or Problem · 1

    THIS IS A DUPLICATE REPORT THAT WAS INADVERTENTLY SENT VIA THE ON-LINE REPORTING SYSTEM THAT SHOULD BE FOR HEALTH PROFESSIONALS OR CONSUMERS ONLY. IT WAS REPORTED TO OLSEN MEDICAL THAT AT SOMETIME EITHER DURING OR AFTER A HERNIA REPAIR, THE CORD (WITH AN UNKNOWN LOT NUMBER) SPARKED AND CAUGHT A SURGICAL DRAPE ON FIRE. THERE WAS NO PATIENT INFORMATION REPORTED BECAUSE THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CORD REUSABLE MONOPOLAR CORD GEI OLSEN MEDICAL 90056 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other