BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPOUCH RETRIEVER

    MDR report key: 2032644 · Received March 7, 2011

    Report

    Report Number
    2032644
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ETHICON ENDOSURGERY LLC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    A 10 ML ENDOPOUCH BROKE INTO 2 SEPARATE PIECES WHILE IN USE. PIECES RETRIEVED, SPECIMEN RETRIEVED WITH NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPOUCH RETRIEVER ENDOPOUCH RETRIEVER GCJ ETHICON ENDOSURGERY LLC A94580P00 G4TA08

    Patients

    Seq Age Sex Outcome Treatment
    1 *