BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 106096 · Received June 16, 1997

    Report

    Report Number
    1527736-1997-01676
    Event Type
    Injury
    Date Received
    June 16, 1997
    Date of Event
    June 16, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH DISPOSABLE SURGICAL TROCAR WHILE PERFORMING A LAP APPENDECTOMY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973819. 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, CLOSED 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, VISUAL EXAMINATION AND FUNCTIONAL TEST, THE INSTRUMENT WAS FOUND TO BE CONFORMING. THE EXPERIENCE REPORTED BY THE SURGEON COULD NOT BE REPEATED DURING TESTING. NO CONCLUSION COULD BE REACHED AS TO HOW THE REPORTED "SHIELD DID NOT RETRACT TO COVER THE BLADE" OCCURED. CO REVIEWS EACH INCIDENCE 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 APPENDECTOMY. IT WAS REPORTED THE SURGEON WENT TO INSERT THE TROCAR AND IT WAS INSERTED INTO THE UTERUS. THE HOSP STAFF STATED THE SHIELD DID NOT RETRACT BACK TO COVER THE BLADE. THE SHIELD WAS STILL IN THE EXPOSED POSITION WHEN REMOVED FROM THE UTERUS. THE PT WAS 20 WEEKS PREGNANT. THE CASE WAS CONVERTED TO AN OPEN PROCEDURE. THERE WERE NO OTHER CONSEQUENCES. THE LOT NUMBER IS 86632, CATALOG NUMBER GA102304-THIS IS FROM A PACK MEDSURG ISOLYSER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA K4652D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention