BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CATCH II

    MDR report key: 4181830 · Received October 13, 2014

    Report

    Report Number
    MW5038602
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON USE OF THE COVIDIEN ENDO CATCH II SPECIMEN RETRIEVAL POUCH, IT WAS NOTED THAT THE RETRIEVAL POUCH WAS NOT ATTACHED TO THE METAL RIM OF THE DEVICE. DIAGNOSIS OR REASON FOR USE: LAPAROSCOPIC ASSISTED ESOPHAGECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647177 ENDO CATCH II SPECIMEN RETIEVAL POUCH GCJ COVIDIEN 173049 J4D2257X

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR