BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 1915576 · Received February 12, 2008

    Report

    Report Number
    1527736-2008-00816
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GALL BLADDER PROCEDURE, THE BAG'S RING WAS BROKEN. UNKNOWN HOW CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER SPEC BAG GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4CJ10

    Patients

    Seq Age Sex Outcome Treatment
    1