BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY, INC.

    MDR report key: 451739 · Received April 1, 2003

    Report

    Report Number
    MW1028028
    Event Type
    Malfunction
    Date Received
    April 1, 2003
    Date of Event
    January 30, 2003
    Report Date
    March 19, 2003
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    MFJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC HERNIA REPAIR. USING ETHICON ENDO SUTURE SYSTEM. NEEDLE BROKE OFF FROM SUTURE. X-RAY CONFIRMS METALLIC FRAGMENT IN PT - FRAGMENT NOT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON ENDO-SURGERY, INC. ENDO SUTURE MFJ ETHICON ENDO-SURGERY, INC. SW120 P4M38P

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other