BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1780788 · Received July 27, 2010

    Report

    Report Number
    3006451981-2010-00063
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 20, 2010
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A C.R. RESECTION. THE SURGEON ACTIVATED THE INSTRUMENT BUT A SEAL WAS NOT CREATED. WHEN THE SURGEON CUT WITH THE BLADE OF THE DEVICE THERE WAS BLEEDING. SEE MFR REPORT # 1717344-2010-00505. A SECOND LS1037 WAS OPENED AND THE SAME THING HAPPENED. THE PROCEDURE WAS INITIALLY LAPAROSCOPIC BUT IT WAS CONVERTED TO OPEN DUE TO THE FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0A0004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R (B) (4)| FORCETRIAD-ELECTROSURGICAL GENERATOR