BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRSEAL 5MM TROCAR

    MDR report key: 17852689 · Received September 29, 2023

    Report

    Report Number
    MW5146301
    Event Type
    Death
    Date Received
    September 29, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 25, 2023
    Manufacturer
    CONMED CORPORATION
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE REPORTED EVENT WAS THAT AN AIRSEAL 5MM TROCAR WAS PLACED, POSSIBLY ON THE RIGHT FLANK, AND COULD POTENTIALLY HAVE BEEN RELATED TO AN INJURY SUSTAINED BY THE PATIENT, WHO THEN EXPIRED INTRA-OPERATIVELY. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971891 AIRSEAL 5MM TROCAR LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death