BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUROS

    MDR report key: 1151947 · Received September 5, 2008

    Report

    Report Number
    MW5008217
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 5, 2008
    Manufacturer
    SUROS SURGICAL SYSTEMS, INC.
    Product Code
    NEU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING MRI GUIDED BIOPSY OF LEFT BREAST; DURING PROCEDURE THE RADIOLOGIST COULD NOT DEPLOY THE METALLIC CLIP FOR SITE MARKING PURPOSES. SECOND DEVICE OBTAINED AND SITE MARKED. THERE WAS NO HARM TO PT WHO WAS DISCHARGED LATER THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUROS ATEC TRIMARK TD 13-MR BIOPSY SITE MARKER NEU SUROS SURGICAL SYSTEMS, INC. 709009

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR