BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 2854951 · Received November 20, 2012

    Report

    Report Number
    3006451981-2012-00207
    Event Type
    Death
    Date Received
    November 20, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 24, 2012
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT A PIECE OF THE HANDLE BROKE DURING USE. THE PIECE FELL INTO THE PT CAVITY BUT WAS RETRIEVED. THERE WAS NO PT INJURY AS A RESULT OF THIS ISSUE. FIVE DAYS AFTER THE SURGERY, THE PT DIED OF A HEART ATTACK. THE PT WAS SAID TO BE IN POOR HEALTH PRIOR TO SURGERY. THE SITE HAS INDICATED THAT THEY DO NOT SEE A CONNECTION BETWEEN THE INCIDENT AND THE PT'S DEATH FIVE DAYS LATER. NO FURTHER INFO HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death