BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH REPOSABLE TROCAR

    MDR report key: 161667 · Received April 6, 1998

    Report

    Report Number
    1527736-1998-01057
    Event Type
    Malfunction
    Date Received
    April 6, 1998
    Date of Event
    March 10, 1998
    Report Date
    March 10, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    961716/50317: THIS MEDWATCH 1527736-1998-1057 IS A DUPLICATE OF MADWATCH NUMBER 1527736-1998-1658.

    Additional Manufacturer Narrative · 1

    961716/50317: THIS MEDWATCH 1527736-1998-1057 IS A DUPLICATE OF MEDWATCH NUMBER 1527736-1998-1658.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY CO2 ESCAPED FROM THE 512DH TROCAR WHEN THE INSTRUMENT WAS REMOVED DURING CAUTERIZATION. WHEN THERE WAS A 5 OR 10 MIN INSTRUMENT IN PLACE THE LEAK STOPPED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH REPOSABLE TROCAR 512DH GCJ ETHICON ENDO-SURGERY, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other