BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 110005 · Received July 31, 1997

    Report

    Report Number
    1527736-1997-01861
    Event Type
    Malfunction
    Date Received
    July 31, 1997
    Date of Event
    June 26, 1997
    Report Date
    July 4, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH DILATING TIP TROCAR ON 6/26/97 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 # 974312. 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, CONFORMING; FLAPPER DOOR FUNCTIONAL, CONFORMING AND LOCKOUT FUNCTIONAL, CONFORMING; ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, VISUAL EXAMINATION AND FUNCTIONAL TEST PERFORMED, THE INSTRUMENT WAS FOUND TO ARM, AND THE SAFETY SHIELD WAS FOUND TO RETRACT AND LOCKOUT PROPERLY. NO CONCLUSION COULD BE REACHED AS TO HOW THE REPORTED "SAFETY SHIELD WOULD NOT RETRACT" OCCURRED. NOTE; THIS WAS ORIGINALLY REPORTED AS AN RPO. CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINUOUSLY IMPROVE CO'S 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 SAFETY SHIELD WOULD NOT RETRACT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA J45L21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other