BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUT SUTURE

    MDR report key: 1304448 · Received February 3, 2009

    Report

    Report Number
    MW5009861
    Event Type
    Malfunction
    Date Received
    February 3, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 3, 2009
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PRODUCT AUTO SUTURE COVIDIEN 5MM ROTICULATOR ENDO GRASPER PRODUCT # 174233, LOT # P8L0708. THE END OF GRASPER BROKE OFF DURING LAPAROSCOPIC SURGERY PROCEDURE. THE DISTAL PORTION WAS RETRIEVED. NO APPARENT INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUT SUTURE ROTICULATOR ENDO GRASP 5 MM GCJ UNITED STATES SURGICAL 174233 P8 L00708

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR