BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 X 6 ENDOBAG SPECIMEN RETRIEVAL SYSTEM

    MDR report key: 2904815 · Received December 4, 2012

    Report

    Report Number
    2647580-2012-00766
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 9, 2012
    Manufacturer
    COVIDIEN, FORMERLY USSC
    Product Code
    GCJ
    PMA / PMN Number
    K913762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE BAG HAD BEEN TORN AND COULD NOT REMOVE THE GALLBLADDER. USING ANOTHER, THE PROCEDURE WAS COMPLETED. NO BLEEDING. NO TISSUE DAMAGE. NOTHING FELL INTO CAVITY. NO PT HARM. OPERATING ROOM TIME NOT EXTENDED. ANOTHER ENDOBAG FROM THE SAME LOT WILL BE ALSO RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 X 6 ENDOBAG SPECIMEN RETRIEVAL SYSTEM SINGLE USE SPECIMEN RETRIEVAL PRODUCT GCJ COVIDIEN, FORMERLY USSC P1J0669X

    Patients

    Seq Age Sex Outcome Treatment
    1