BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 140252 · Received December 23, 1997

    Report

    Report Number
    1527736-1997-03570
    Event Type
    Malfunction
    Date Received
    December 23, 1997
    Date of Event
    November 25, 1997
    Report Date
    November 25, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED WITH NO LOT IDENTIFICATION. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: BULLET TIP CONDITION, CONFORMING; DESUFFLATION LEVER CONDITION, CONFORMING; INNER GASKET CONDITION, CONFORMING; LATCH CONDITION, CONFORMING; OBTURATOR CONDITION, CONFORMING; OUTER GASKET CONDITION, CONFORMING; RESET BUTTON CONDITION, CONFORMING; SLEEVE CONDITION, CONFORMING; STOPCOCK CONDITION, CONFORMING AND TROCAR CONDITION, CONFORMING. FUNCTIONAL TESTS & RESULTS: DOES SAFETY SHIELD RETRACT, NONCONFORMING; FLAPPER DOOR FUNCTIONAL, CONFORMING AND LOCKOUT FUNCTIONAL, CONFORMING. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONFIRMED THAT THE REPORTED "SURGEON WAS UNABLE TO ARM OR ENGAGE THE REN ARMING DEVICE TO PREPARE THE TROCAR FOR INSERTION" OCCURRED. THE DEVICE WAS EXAMINED AND WOULD NOT ARM AS RECEIVED. THE OBTURATOR HANDLE WELD WAS MEASURED AND FOUND TO BE SKEWED. THE OBTURATOR HANDLE IS WELDED DURING THE ASSEMBLY PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY WHILE USING A 355LD TROCAR THE SURGEON WAS UNABLE TO ARM OR ENGAGE THE RED ARMING DEVICE TO PREPARE THE TROCAR FOR INSERTION. REPEATEDLY THE RED BUTTON WOULD NOT ENGAGE. THE TROCAR WAS NEVER INSERTED INTO THE PT. A NEW 5MM TROCAR WAS OPENED TO COMPLETE THE CASE WITHOUT INCIDENT. THERE WAS NO CONSEQUENCE TO THE PT.

    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