BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE BLUNT TIP LAP SEALER/DIVIDER

    MDR report key: 4092578 · Received September 8, 2014

    Report

    Report Number
    1717344-2014-00798
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 27, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE WAS RETURNED, EVALUATED AND FOUND TO FUNCTION WITHIN SPECIFICATION. THE DEVICE WAS TESTED FOR ACTIVATION AND SEALING FUNCTION ON SIMULATED TISSUE WITH ACCEPTABLE RESULTS. ADDITIONAL TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY. COVIDIEN WAS UNABLE TO CONFIRM THE CUSTOMER¿S REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BLEEDING OF LESS THAN 300CC OCCURRED EVENT THOUGH END TONES, INDICATING A COMPLETED SEAL CYCLE, WERE HEARD. CLIPS WERE USED TO STOP THE BLEEDING. THE TISSUE WAS DESCRIBED AS THICK MESENTERY BY THE COLON. THE PROCEDURE WAS DELAYED BY MORE THAN 30 MINUTES. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550980 LIGASURE BLUNT TIP LAP SEALER/DIVIDER LIGASURE VESSEL SEALING SYS GEI COVIDIEN LP 40800131X

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR