BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 1152727 · Received September 10, 2008

    Report

    Report Number
    1527736-2008-03734
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 9, 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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE DEPLOYED INSIDE PT BUT SURGEON COULD NOT CLOSE FOR REMOVAL. THE PLUNGER WAS STUCK ALL THE WAY DOWN, AND WOULD NOT PULL BACK. DEVICE AND TROCAR REMOVED FROM PT AND ANOTHER DEVICE WAS USED TO COMPLETE. THERE WERE NO PT CONSEQUENCES. DEVICE IS BEING RETAINED BY ACCOUNT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1