BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE BLUNT TIP LAP SEALER/DIV

    MDR report key: 2891015 · Received November 9, 2012

    Report

    Report Number
    1717344-2012-01156
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 18, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY, BLEEDING OCCURRED FROM THE SHORT GASTRIC VESSELS ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. THE SURGEON USED A CLIP APPLIER TO CONTROL THE BLEEDING. THE SURGERY WAS DELAYED OVER THIRTY MINUTES AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE BLUNT TIP LAP SEALER/DIV LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK