BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 109902 · Received July 31, 1997

    Report

    Report Number
    1527736-1997-01858
    Event Type
    Malfunction
    Date Received
    July 31, 1997
    Date of Event
    July 3, 1997
    Report Date
    July 3, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH DILATING TIP 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 #974316. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: DESUFFLATION LEVER CONDITION, OUTER GASKET CONDITION, SLEEVE CONDITION, AND STOPCOCK CONDITION, CONFORMING; AND INNER GASKET CONDITION, MISSING. FUNCTIONAL TESTS & RESULTS: FLAPPER DOOR FUNCTIONAL, CONFORMING. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO, PHOTOGRAPHIC EVIDENCE RECEIVED, AND VISUAL EXAMINATION; IT WAS CONFIRMED THAT THE REPORTED "GASKET FELL INTO THE PATIENT". THE INNER GASKET WAS MISSING. NO CONCLUSION COULD BE REACHED AS TO HOW THE INNER GASKET HAD DISLODGED FROM ITS ORIGINAL POSITION. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE THE PRODUCTS AND PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE GASKET FELL INTO THE PT. THE GASKET WAS RETRIEVED FROM THE PT BODY. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other