BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPOUCH RETRIEVER

    MDR report key: 2854120 · Received December 3, 2012

    Report

    Report Number
    3005075853-2012-05423
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED; NO RESPONSE HAS BEEN RECEIVED TO DATE. THE POUCH DEVICE WAS RECEIVED IN GOOD CONDITION. THE DEVICE HAD BEEN FULLY DEPLOYED. THERE WAS NO BAG AND NO SUTURE RETURNED WITH THE DEVICE. THE ANTI-BACKUP WAS ENGAGED AND THE DISTAL CAM WAS LOCKED OUT INTO THE SUPPORT TUBE. THE ANTI-ROTATION, FINGER/THUMB RINGS, AND PUSH-PULL ROD WERE INTACT. THE SUPPORT ARMS WERE DEPLOYED ON ONE SIDE OF THE DISTAL PLUG. THE SUPPORT ARMS WERE ATTACHED TO THE PUSH-PULL ROD AND WERE IN GOOD CONDITION. THE SUPPORT ARM PIN WAS INTACT. THE DISTAL PLUG ASSEMBLY WAS IN GOOD CONDITION. SINCE THE BAG WAS NOT RETURNED FOR ANALYSIS WE WERE NOT ABLE TO RE-CREATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE SURGEON WAS REMOVING THE GALL BLADDER THE DEVICE MISFIRED AND THE GALL BLADDER FELL OUT OF THE DEVICE. THEY PERFORMED LAPAROSCOPIC FLUOROSCOPY AND THEY DID NOT FIND THE GALL GLADDER IN THE PATIENT OR IN THE SURGICAL FIELD. THE CASE WAS COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention