BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYONICS

    MDR report key: 1591212 · Received January 28, 2010

    Report

    Report Number
    1591212
    Event Type
    Malfunction
    Date Received
    January 28, 2010
    Date of Event
    January 28, 2010
    Report Date
    January 28, 2010
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A RIGHT SHOULDER ARTHROSCOPY PROCEDURE, AN ARTHROSCOPIC TROCAR WAS BEING USED. WHEN IT WAS INSERTED TO THE SITE, A TINY BLACK COLORED PARTICLE CAME OUT FROM THE INSTRUMENT. THE PARTICLE WAS THEN SUCTIONED OUT. DOCTOR CONFIRMED.THE DEBRIS APPEARS TO BE FROM THE RUBBER WASHER INSIDE OF THE CANNULA THAT MAY HAVE BROKEN DOWN. DEVICE IS A REUSABLE TROCAR WHICH HAS BEEN HELD ASIDE. MANUFACTURER RESPONSE (AS PER REPORTER) FOR ATRHROSCOPIC CANNULA, DYONICS ARTHROSCOPIC CANNULA.WILL RELEASE TO MANUFACTURER AND REQUEST MANUFACTURER SHARE FINDINGS OF ANALYSIS WITH FACILITY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS ARTHROSCOPIC CANNULA HRX SMITH & NEPHEW INC., ENDOSCOPY DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR