BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO PATH

    MDR report key: 1545802 · Received November 16, 2009

    Report

    Report Number
    MW5013676
    Event Type
    Malfunction
    Date Received
    November 16, 2009
    Date of Event
    November 12, 2009
    Report Date
    November 12, 2009
    Manufacturer
    ETHICON
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CAP RIPPED WHEN TIGHTENED AROUND SURGEON'S HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO PATH DEXTRUS SEAL CUP ASSEMBLY GCJ ETHICON F4P71Y

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR