BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE SYSTEM GENERATOR-DOM

    MDR report key: 968867 · Received December 21, 2007

    Report

    Report Number
    1219930-2007-00855
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    May 31, 2007
    Report Date
    December 7, 2007
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: DECEMBER 21, 2007. TO DATE, THE INCIDENT GENERATOR HAS NOT BEEN RECEIVED FOR EVALUATION, BUT THE SITE HAS REPORTED THEY ARE SENDING IT BACK FOR EVALUATION AS NOW THEY HAVE HAD THREE ADVERSE EVENTS FOLLOWING SURGERIES IN WHICH THIS GENERATOR WAS USED. THE SITE REPORTED ALL THREE ADVERSE EVENTS TO COVIDIEN LP (FORMERLY VALLEYLAB) IN 2007. THE THREE INCIDENTS RANGE IN DATE FROM 2006 THROUGH 2007. THE OTHER TWO ADVERSE EVENTS ARE REPORTED ON MFR REPORTS #1219930-2007-00857 AND 1219930-2007-00858. THE ACCESSORY HANDPIECES HAVE ALL BEEN DISCARDED. THE SITE HAS BEEN ASKED TO PROVIDE THE NAME OF THE LARGER FACILITY THE PATIENT WAS TRANSFERRED TO SO THAT ADDITIONAL INFORMATION MAY BE OBTAINED. THE PATIENT AGE AND MEDICAL HISTORY WAS ALSO REQUESTED. THIS INFORMATION HAS NOT YET BEEN PROVIDED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT EIGHT OR NINE DAYS AFTER AN OPEN BOWEL RESECTION, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND WAS FOUND TO HAVE AIR IN THE BOWELS FROM A BOWEL PERFORATION. AS THE OPERATING SITE IS A SMALL RURAL HOSPITAL, THE PATIENT WAS TRANSFERRED TO A LARGER MEDICAL CENTER AND REOPERATED ON. AN ILEOSTOMY WAS DONE. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE SYSTEM GENERATOR-DOM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| L| R LS1120| LIGASURE ATLAS 20 CM