BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON ENDOPATH

    MDR report key: 19714 · Received February 13, 1995

    Report

    Report Number
    19714
    Event Type
    Other
    Date Received
    February 13, 1995
    Date of Event
    July 12, 1994
    Report Date
    July 25, 1994
    Manufacturer
    ETHICON, INC.
    Product Code
    FBQ
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN SURGEON INSERTED TROCAR INTO ABDOMEN, HE NOTICED GAS LEAKING FROM IT. WHEN HE CHECKED INSIDE THE TROCAR, HE NOTICED THAT THE DIAPHRAGM OF THE SLEEVE WAS MISSING A PIECE OF THE PLASTIC. HE IS NOT SURE IF DEFECT WAS PRESENT FROM BEGINNING OR NOT. SURGEON SEARCHED EXTENSIVELY INSIDE PELVIS IN EVENT PIECE MIGHT HAVE GOTTEN INTO ABDOMEN, BUT FOUND NOTHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDOPATH 512MM TRI-STAR TROCAR W/RADIOLUSCENT SLEEVE FBQ ETHICON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other