BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSUTURE - PREMIUM SURGICLIP S-9.0

    MDR report key: 2110283 · Received May 23, 2011

    Report

    Report Number
    2110283
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 23, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE TIME OF USE SURGICLIP MALFUNCTIONED AND BEGAN PROJECTILE SHOOTING OF CLIPS.======================MANUFACTURER RESPONSE FOR PREMIUM SURGICLIP S-9.0, AUTOSUTURE - PREMIUM SURGICLIP S-9.0 (PER SITE REPORTER)======================THEY WOULD LIKE THE ITEM RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE - PREMIUM SURGICLIP S-9.0 CLIP APPLIER FZP COVIDIEN * P1A1210

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR