BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE

    MDR report key: 317654 · Received February 23, 2001

    Report

    Report Number
    MW1021172
    Event Type
    Malfunction
    Date Received
    February 23, 2001
    Date of Event
    November 11, 2000
    Report Date
    February 23, 2001
    Manufacturer
    UNITED STATES COPR.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC SURGERY THE ENDO CLIP #176620 WAS UNABLE TO SUTURE WHILE IN SITU. UNABLE TO REM0VE THE ENDO CLIP THROUGH THE TROCAR UNTIL THE CASE WAS OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7419 AUTO SUTURE ENDO CLIP 5MM GDO UNITED STATES COPR. 176620 NO. 6115

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other