BEUDAMED
    FDA Adverse Event Summary report: N

    ENDOPATH XCEL DILATING TIP TROCAR

    MDR report key: 3010522 · Received March 15, 2013

    Report

    Report Number
    3010522
    Date Received
    March 15, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SHEATH DID NOT DEPLOY OVER BLADE OF TROCAR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAP CHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110631 ENDOPATH XCEL DILATING TIP TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR