BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOPATH TROCAR

    MDR report key: 286381 · Received July 18, 2000

    Report

    Report Number
    1527736-2000-03201
    Event Type
    Malfunction
    Date Received
    July 18, 2000
    Date of Event
    June 25, 2000
    Report Date
    June 29, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT(1) DEVICE WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED BY THE REP THAT THE 35NST TROCAR WAS USED. WHEN INSERTING THE SECONDARY TROCAR DUE TO ABDOMINAL WALL TENTING, THE SURGEON USED A GRASPER TO PROVIDE INTERNAL UPWARD PRESSURE WHERE THE TROCAR WAS BEING INSERTED. UPON ENTRY THE CLEAR NBO TIP WAS MISSING AND LODGED IN THE ABDOMINAL WALL. THE PIECE WAS RETRIEVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOPATH TROCAR TROCAR STABILITY SLEEVES GCJ ETHICON ENDO-SURGERY, INC. NA N4HN64

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other