BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 5620359 · Received April 26, 2016

    Report

    Report Number
    MW5061977
    Event Type
    Injury
    Date Received
    April 26, 2016
    Date of Event
    April 25, 2016
    Report Date
    April 26, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTOSTOMY, AN ENDOPOUCH RETRIEVER WAS INSERTED INTO THE ABDOMEN THROUGH A TROCAR. WHEN THE SURGEON ATTEMPTED TO FIRE IT, TO DISCHARGE THE ENDOPATH, IT DID NOT FEEL RIGHT. WHEN FIRED, THERE WAS NO STRING AND NO ENDOPOUCH EXPELLED FROM THE TUBULAR PORTION OF THE DEVICE. THE DEVICE WAS HANDED OFF THE FIELD AND BROKEN OPEN TO DETERMINE IF ANY OF THE COMPONENTS WERE RETAINED WITHIN THE TUBULAR STRUCTURE. NONE WERE FOUND. A SWEEP SURVEILLANCE OF THE ABDOMEN WAS CONDUCTED; NO COMPONENTS OF THE STRING AND/OR ENDOPOUCH WERE FOUND UPON VISUAL INSPECTION. (THERE ARE NO RADIOPAQUE COMPONENTS THAT COULD BE FOUND ON X-RAY.) THE SURGEON BELIEVES THERE ARE NO RETAINED COMPONENTS. THE MFR IS SENDING MATERIALS TO RETURN THE INSTRUMENT; WE EXPECT TO SHIP IT ON THURSDAY 04/28/2016. (B)(4). (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262626 ETHICON ENDO-SURGERY, LLC ENDOPOUCH RETRIEVER 26CM, 10MM GCJ ETHICON ENDO-SURGERY, LLC 26CM/10MM POUCH N4L39J

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention