BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR

    MDR report key: 1960255 · Received January 6, 2011

    Report

    Report Number
    1960255
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT IS A (B)(6) MALE ADMITTED TO THE MEDICAL CENTER ON (B)(6) 2011 FOR A SCHEDULED LAPAROSCOPIC CHOLECYSTECTOMY AND UMBILICAL HERNIA REPAIR. RN REPORTED THAT AT 1045 HRS, DURING THE SURGERY, BOTH ASCENT REPROCESSED TROCARS WERE FOUND TO BE LEAKING GAS DURING INSTRUMENT INSERTION. THE SURGERY WAS COMPLETED WITHOUT DIFFICULTY AND THERE WAS NO HARM TO THE PT. ADD'L LOT# 1351104

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCAR SURGICAL CANNULA/TROCAR GCJ ETHICON ENDO-SURGERY, INC. TWO USED BOTH B5LT 1249123
    2 TROCAR SURGICAL CANNULA/TROCAR GCJ ETHICON ENDO-SURGERY, INC. TWO USED BOTH B5LT 1351104

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other