BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 4949092 · Received July 29, 2015

    Report

    Report Number
    9612501-2015-00443
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    May 20, 2015
    Report Date
    July 20, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: GYNECOLOGY. ACCORDING TO THE REPORTER: PATIENT HAVING LAP PROCEDURE FOR RUPTURED ECTOPIC PREGNANCY. THE FALLOPIAN TUBE SEGMENTS AND POC WERE REMOVED USING THE COVIDIEN TROCAR AND ENDO POUCH GOLD SPECIMEN RETRIEVAL POUCH 10MM. AFTER REMOVAL OF SPECIMEN AND THE SURGEON WAS VISUALIZING AND WASHING OUT THE ABDOMEN BEFORE CLOSURE AND NOTED FRAGMENTS OF THE BAG PRESENT IN THE PATIENT'S ABDOMEN. THE SURGEON THEN RETRIEVED 2 PIECES OF THE POUCH FROM THE PATIENTS ABDOMEN THAT HAD TORN OFF WHEN THE POUCH WAS PULLED BACK THROUGH THE TROCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494814 ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL LARYNGOSCOPE, ENDOSCOPE GCI COVIDIEN 173050G J5B1462MX

    Patients

    Seq Age Sex Outcome Treatment
    1