BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 200912 · Received December 4, 1998

    Report

    Report Number
    1527736-1998-03923
    Event Type
    Malfunction
    Date Received
    December 4, 1998
    Date of Event
    November 6, 1998
    Report Date
    November 9, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A.DE C.V.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ILT WAS REPORTED BY THE REP THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE TROCAR HAD A LEAKY GASKET. IT CAME FROM A FDC15 KIT. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCARS GCJ ETHICON ENDO-SURGERY, INC. S.A.DE C.V. NA L4C681

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other