BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOCATCH GOLD 10MM SPECIMEN POUCH INTL

    MDR report key: 2112226 · Received April 29, 2011

    Report

    Report Number
    9612501-2011-00028
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    DAVIS AND GECK CARIBE, LTD.
    Product Code
    GCI
    PMA / PMN Number
    K922123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: IT WAS STATED THAT 2 FAILED DEVICES WERE RECOVERED ALONG WITH PACKAGING. BOTH DEVICES FAILED IN APPROXIMATELY THE SAME LOCATION, ABOUT 25 MM FROM THE DISTAL END AND TORE THE PLASTIC MATERIAL OPEN. NO PIECES OF THE MATERIAL APPEAR TO BE MISSING. WILL FILE FDA MEDWATCH REPORT AND GIVE SAMPLES TO THE MANUFACTURER FOR ANALYSIS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE DEVICE IN QUESTION WAS REMOVED FROM THE SURGICAL FIELD AND A NEW ENDOCATCH 10 MM WAS OPENED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOCATCH GOLD 10MM SPECIMEN POUCH INTL SINGLE USE SPECIMEN RETRIEVAL PRODUCT GCI DAVIS AND GECK CARIBE, LTD. J1A0047

    Patients

    Seq Age Sex Outcome Treatment
    1