BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH XCEL

    MDR report key: 2994063 · Received March 1, 2013

    Report

    Report Number
    2994063
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON CLAIMS THAT BLADED TROCAR WAS DULL AS HE ATTEMPTED INSERTION; HAD DIFFICULTY INSERTING; SURGEON STATES "REPROCESSED BLADED TROCARS ARE NO GOOD." THERE WAS NO INJURY OR BLOOD LOSS TO PATIENT AS A RESULT OF THE DEVICE EVENT.======================MANUFACTURER RESPONSE FOR BLADED TROCAR, ETHICON ENDO-SURGERY TROCAR XCEL (PER SITE REPORTER).======================THEY ARE GOING TO PICK UP THE DEVICE AND PROVIDE US WITH A REPORT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC PROCEDURE WITH EXCISION OF LEFT OVARIAN CYST REMOVAL OF BOWEL OMENTAL ADHESIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89317 ENDOPATH XCEL LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC 5MM X 100MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR