BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO POUCH

    MDR report key: 1031855 · Received April 7, 2008

    Report

    Report Number
    1031855
    Event Type
    Injury
    Date Received
    April 7, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 7, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ENDO-POUCH MALFUNCTIONED WHEN USED AND DID NOT "GRAB" THE APPENDIX. IT WAS DISCARDED AND ANOTHER ENDO-POUCH USED WITHOUT PROBLEMS. LATER, DISCOVERED THAT THE ENDO-POUCH HAD BROKEN, AND A 10-15 CM PIECE OF METAL REMAINED IN THE ABDOMEN REQUIRING A SECOND SURGERY TO RETRIEVE. THE PATIENT BECAME SEPTIC AND IS NOW ON A VENTILATOR AND VASOPRESSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO POUCH RETRIEVAL DEVICE, ENDOSCOPIC GCJ ETHICON ENDO-SURGERY, INC. P30162P02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R CARDIAC DRUGS| CARDIAC DRUGS