BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH

    MDR report key: 214354 · Received March 12, 1999

    Report

    Report Number
    MW4002437
    Event Type
    Malfunction
    Date Received
    March 12, 1999
    Date of Event
    January 3, 1999
    Report Date
    January 26, 1999
    Manufacturer
    ETHICON ENDO-SURGERY, INC., QUALITY ASSURANCE/MED DEV. DIV.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    35 YEAR OLD IN OR FOR A LAPAROSCOPIC CHOLECYSTECTOMY. DURING PROCEDURE SURGEON WAS UNABLE TO MAINTAIN CARBON DIOXIDE LEVEL IN THE ABDOMEN. ANOTHER SET OF DEVICES WAS OBTAINED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE CHOLECYSTECTOMY TRAY GCJ ETHICON ENDO-SURGERY, INC., QUALITY ASSURANCE/MED DEV. DIV. * L4CC14

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other