BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE IMPACT LF4318

    MDR report key: 5153591 · Received October 15, 2015

    Report

    Report Number
    1717344-2015-00723
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    May 22, 2015
    Report Date
    October 6, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF FOLLOW-UP REPORT : 11/02/2015. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FORCETRIADS WITH SERIAL NUMBERS (B)(4) INDICATED THAT THESE WERE RELEASED MEETING ALL SPECIFICATIONS AS MANUFACTURED. HOWEVER, IT IS UNKNOWN WHAT GENERATOR OF THESE TWO WAS USED FOR THIS PROCEDURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY AND BILATERAL SALPINGO OOPHORECTOMY. A LIGASURE IMPACT DEVICE WAS IN USE ALONG WITH A FORCETRIAD ENERGY PLATFORM DURING THE PROCEDURE. THE PATIENT PRESENTED AN ISSUE OF LEAKING URINE TO THE CLINIC POST-OPERATIVELY. AN INTERNAL INVESTIGATION WAS PERFORMED AT THE SITE BY THE SENIOR GYNECOLOGY CONSULTANT AND LAPAROSCOPY LEAD OF THAT LOCATION. THIS PERSON CONFIRMED THAT THE INJURY WAS CAUSED BY "SURGICAL MISTAKE" AND NOT BY ANY INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684022 LIGASURE IMPACT LF4318 LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other