BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONCOSMART PROGUIDE NEEDLE

    MDR report key: 1070946 · Received May 7, 2008

    Report

    Report Number
    9611894-2008-00002
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 2, 2008
    Report Date
    May 6, 2008
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    PMA / PMN Number
    K06039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF NEEDLES FOR AN INTERSTITIAL GYN IMPLANT FOR URETHRAL CANCER USING HDR BRACHYTHERAPY, THE TIPS OF TWO NEEDLES BROKE OFF (A FEW MILLIMETERS). THE FIRST NEEDLE WAS INSERTED THROUGH A TEMPLATE GRID. THE PHYSICIAN REMOVED THE NEEDLE BECAUSE OF POSITIONING AND DISCOVERED THE TIP HAD BROKEN OFF. A SECOND NEEDLE WAS INSERTED THROUGH THE SAME GRID POINT. AGAIN, THE PHYSICIAN DID NOT LIKE THE POSITIONING AND REMOVED THE NEEDLE. THE TIP ON THE SECOND NEEDLE BROKE OFF AS WELL. THE REST OF THE NEEDLES FOR THE IMPLANT WERE INSERTED WITHOUT PROBLEMS AND THE TREATMENT WENT ACCORDING TO PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONCOSMART PROGUIDE NEEDLE JAQ, HDR REMOTE AFTER LOADING ACCESSORY JAQ NUCLETRON BV 189616 072396.001

    Patients

    Seq Age Sex Outcome Treatment
    1