BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL BLADELESS TROCAR

    MDR report key: 3012753 · Received March 8, 2013

    Report

    Report Number
    3012753
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ETHICON ENDO SURGERY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US

    Narratives

    Description of Event or Problem · 1

    THE 12 MM TROCAR WAS BEING USED APPROPRIATELY FOR A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS WITH LYSIS OF ADHESIONS. AT SOME POINT IT WAS DISCOVERED THAT THE TIP HAD BEEN BROKEN AND A PIECE WAS MISSING. A PIECE OF TROCAR WAS RECOVERED FROM THE PATIENT USING GRASPERS. THE DEFFECTIVE TROCAR WAS REMOVED AND A NEW ONE WAS INSERTED IN THE PORT SITE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?1. LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS.2. LAPAROSCOPIC LYSIS OF ADHESIONS.3. OPEN INCISIONAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100380 ENDOPATH XCEL BLADELESS TROCAR LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ETHICON ENDO SURGERY * K4C01D

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR