BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, LLC

    MDR report key: 2048286 · Received April 5, 2011

    Report

    Report Number
    MW5020184
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PIECE BROKE DURING SURGICAL PROCEDURE. NO HARM TO PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, LLC 1 ENDOPATH ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER GDW ETHICON ENDO-SURGERY, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR