BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH SURGICAL TROCAR

    MDR report key: 117472 · Received September 3, 1997

    Report

    Report Number
    1527736-1997-02201
    Event Type
    Malfunction
    Date Received
    September 3, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 5, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #975057. VISUAL INSPECTIONS & RESULTS: BLADE CONDITION, CONFORMING; CAM CONDITION, DESUFFLATION LEVER CONDITION, CONFORMING; INNER GASKET CONDITION, CONFORMING; LATCH CONDITION, CONFORMING; LENS ENGAGEMENT, OBTURATOR CONDITION, CONFORMING; OUTER GASKET CONDITION, CONFORMING; SLEEVE CONDITION, CONFORMING; AND STOPCOCK CONDITION, CONFORMING; FUNCTIONAL TESTS & RESULTS: LATCH FUNCTION PROPERLY, CONFORMING; AND SAFETY SHIELD FUNCTION PROPERLY, CONFORMING. CO REVIEW EACH INCIDENCE 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 DIAGNOSTIC LAPAROSCOPY. IT WAS REPORTED THE SAFETY SHIELD DID NOT RETRACT. THERE WAS NO OTHER INFO AVAILABLE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH SURGICAL TROCAR SURGICAL TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA J4406C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other