BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPOUCH RETRIEVER

    MDR report key: 1935729 · Received December 22, 2010

    Report

    Report Number
    3005075853-2010-07338
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 30, 2008
    Report Date
    December 13, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR EVALUATION. AS EES BECAME MADE AWARE OF THE COMPLAINT THROUGH LITIGATION, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, UPON ATTEMPTING TO REMOVE THE POUCH, MULTIPLE GALLSTONES FELL INTO THE ABDOMINAL CAVITY. THE GALLBLADDER STONES WERE DISBURSED INTO THE ABDOMINAL CAVITY THEREAFTER CAUSING THE PATIENT TO UNDERGO MULTIPLE SURGICAL PROCEDURES. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention