BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER SPEC BAG

    MDR report key: 1190716 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03467
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 15, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THE SURGEON WAS UNABLE TO RELEASE THE HANDLE ON THE RETRIEVER IN ORDER TO REMOVE THE SPECIMEN. THE SURGEON HAD TO PULL OUT THE TROCAR WITH THE OPEN POUCH INSIDE THE TROCAR TO REMOVE THE GALIBLADDER. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER SPEC BAG NONE GCJ ETHICON ENDO SURGERY, INC. (CINCINNATI) NA E4KH6E

    Patients

    Seq Age Sex Outcome Treatment
    1