BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1865034 · Received October 5, 2010

    Report

    Report Number
    1717344-2010-00680
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 5, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(6). DATE OF INITIAL REPORT: (B)(6)2010. THE INCIDENT SAMPLE HAS BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR 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 DURING A GYN PROCEDURE, THAT TWO DEVICES WOULD NOT CUT OR RELEASE WHILE ON TISSUE. IT IS UNKNOWN HOW THE SURGEON EVENTUALLY REMOVED DEVICE, BUT THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY. THE ADDITIONAL DEVICE IN THIS PROCEDURE CAN BE FOUND ON MFR REPORT # 1717344-2010-00665.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK