BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 162580 · Received April 10, 1998

    Report

    Report Number
    1527736-1998-01119
    Event Type
    Malfunction
    Date Received
    April 10, 1998
    Date of Event
    December 29, 1997
    Report Date
    March 16, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.50495. EES#.981870/J. D6: DEVICE RETURNED WITH NO LOT IDENTIFICATION. ENDOPATH DILATING TIP TROCAR: BASED ON THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INNER GASKET IS DISLODGED FROM ITS ORIGINAL POSITION. NO CONCLUSION COULD BE REACHED AS TO HOW THIS OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC CHOLECYSTECTOMY WHILE USING A 511SD THE O RING FELL INTO THE PT'S ABDOMEN. THE SURGEON RETRIEVED THE O RING WITH A GRASPER. THIS WAS AT THE END OF THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other