BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 86262 · Received April 22, 1997

    Report

    Report Number
    1527736-1997-00711
    Event Type
    Malfunction
    Date Received
    April 22, 1997
    Date of Event
    March 24, 1997
    Report Date
    April 22, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH YOUR ENDOPATH DISPSABLE SURGICAL TROCAR WHILE PERFORMING A LAP CHOLECYSTECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #971867. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BULLET TIP CONDITION N/A, DESUFFLATION LEVER CONDITION CONFORM, INNER GASKET CONDITION NOT CONFORM, LATCH CONDITION N/A, OBTURATOR CONDITION N/A, OUTER GASKET CONDTION CONFORM, RESET BUTTON CONDTION N/A, SLEEVE CONDTION CONFORM, STOPCOCK CONDTION OPENED, TROCAR CONDITION N/A. FUNCTIONAL TESTS & RESULTS: DOES SAFETY SHIELD RETRACT N/A, FLAPPER DOOR FUNCTIONAL CONFORM, LOCKOUT FUNCTIONAL N/A. ANALYSIS CONCLUSION: BASED ON THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INNER GASKET WAS DISLODGED FROM IT'S ORIGINAL POSTION. NO CONCLUSION COULD BE REACHED AS TO HOW THIS OCCURRED. CO REVIEWS EACH INCIDENT AS IT OCCURS IN A EFFORT TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE O-RING BROKE OFF OF THE FLAPPER VALVE AND FELL INTO THE ABDOMEN OF THE PT. THE 0-RING WERE RETRIEVED AND A SECOND TROCAR WAS OPENED TO COMPLETE THE CASE. NO CONSEQUENCE TO THE PT. INSTRUMENT FROM FTR32 TRAY, LOT NUMBER K4671K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA K4671K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other