BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER

    MDR report key: 2622254 · Received June 18, 2012

    Report

    Report Number
    2622254
    Event Type
    Malfunction
    Date Received
    June 18, 2012
    Date of Event
    June 16, 2012
    Report Date
    June 18, 2012
    Manufacturer
    ETHICON ENDO -SURGERY
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    SURGEON STATES HE INSERTED AND BAGGED THE APPENDIX SPECIMEN; WHEN HE DEPLOYED THE ENDOBAG THE SPECIMEN SHOT OUT ONE END OF THE BAG AND SPILLED INTO THE ABDOMEN; ANOTHER ENDO POUCH WAS ADDED TO THE SURGICAL FIELD AND OPERATED WITHOUT ERROR AND SPECIMEN WAS RETRIEVED AND REMOVED; ABDOMEN WAS IRRIGATED WITH SUCTION IRRIGATION.======================MANUFACTURER RESPONSE FOR ENDOPOUCH RETRIEVER, ENDOPOUCH RETRIEVER (PER SITE REPORTER).======================TELL STAFF DECOMTAMINATION PROCEDURES ARE PART OF THE ETHICON RETURN KIT AND STAFF SHOULD NOT BE AFRAID TO RETURN A USED ITEM THAT HAS MALFUNCTIONED; ETHICON ENDO WOULD LIKED TO HAVE EXAMINED THIS ITEM; ETHICON ENDO HAS MAILED US A FREE POUCH; TRACKING NUMBER ISSUED BY ETHICON IS PI1-9QOI3M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER ENDOPOUCH RETRIEVER GCJ ETHICON ENDO -SURGERY * J4AT4C

    Patients

    Seq Age Sex Outcome Treatment
    1 *