BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE BLUNT TIP LAP SEALER/DIVIDER

    MDR report key: 4030329 · Received July 17, 2014

    Report

    Report Number
    1717344-2014-00623
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BLEEDING OCCURRED ALTHOUGH END TONES, INDICATING A COMPLETED SEAL CYCLE, WERE HEARD. THE BLEEDING WAS FROM THE PEDICLES OF THE VAGINAL CUFF. RESEALING OF THE PEDICLES WAS PERFORMED TO CONTROL THE BLEEDING. THE BLOOD LOSS WAS MINOR AND THERE WAS NO INJURY TO THE PATIENT. THE DEVICE WAS DISCARDED BY THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420655 LIGASURE BLUNT TIP LAP SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK