BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 2933379 · Received December 21, 2012

    Report

    Report Number
    9612501-2012-00089
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 3, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: APPENDECTOMY. ACCORDING TO THE REPORTER: THE CUSTOMER REPORTS THAT WHEN THEY TRIED TO INTRODUCE THE DEVICE INSIDE THE TROCAR, THE BAG APPEARED TORN VIA THE CAMERA. THEY REMOVED IT AND USED A DIFFERENT ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMEN RETRIEVAL PRODUCT GCI COVIDIEN J2E0113K

    Patients

    Seq Age Sex Outcome Treatment
    1