BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 83264 · Received April 3, 1997

    Report

    Report Number
    1527736-1997-00495
    Event Type
    Malfunction
    Date Received
    April 3, 1997
    Date of Event
    January 28, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH DISPOSABLE SURGICAL TROCAR ON 1/28/97 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 #971464. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BULLET TIP CONDITION, DESUFFLATION LEVER CONDITION, LATCH CONDITION, OBTURATOR CONDITION, OUTER GASKET CONDITION, SLEEVE CONDITION, AND TROCAR CONDITION, CONFORMING; INNER GASKET CONDITION, NON CONFORMING; RESET BUTTON CONDITION, UNARMED; AND STOPCOCK CONDITION, GOOD/CLOSED. FUNCTIONAL TESTS & RESULTS: DOES SAFETY SHIELD RETRACT, FLAPPER DOOR FUNCTIONAL, AND LOCKOUT FUNCTIONAL, CONFORMING. ANALYSIS CONCLUSION: BASED ON VISUAL EXAMINATION IT WAS CONFIRMED THAT THE INNER GASKET BECAME DISLODGED FROM ITS ORIGINAL POSITION. NO CONCLUSION COULD BE REACHED AS TO HOW THE INNER GASKET BECAME DISLODGED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THAT IT FUNCTIONS PROPERLY. THE CENTERING OF THE INSTRUMENT UPON INSERTION OR REMOVAL MAY REDUCE THE POSSIBILITY OF THE SEAL BEING INADVERTENTLY DAMAGED OR DISLODGED. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE GASKET OF THE DEVICE FELL OFF. THE GASKET DID NOT FALL INTO PT. A NEW DEVICE WAS INTRODUCED TO COMPLETE THE CASE. THERE WERE NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA J4527E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other