BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONCOSMART PROGUIDE NEEDLE

    MDR report key: 2933146 · Received January 25, 2013

    Report

    Report Number
    9611894-2013-00001
    Event Type
    Other
    Date Received
    January 25, 2013
    Date of Event
    December 10, 2012
    Report Date
    January 7, 2013
    Manufacturer
    NUCLETRON
    Product Code
    JAQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING MEDICAL DEVICE REPORT IS BEING SUBMITTED TO THE FDA, TO REPLACE REPORT NUMBER (B)(4). WE INADVERTENTLY REPORTED THE 'DATE OF REPORT' AS (B)(4) 2013, WHICH SHOULD HAVE BEEN (B)(4) 2013. ALSO, THE ACTUAL MFR REPORT NUMBER SHOULD HAVE BEEN (B)(4). THIS IS THE ONLY CHANGE TO THIS REPORT.

    Description of Event or Problem · 1

    THE TIP OF A PROGUIDE NEEDLE BROKE-OFF. THE BROKEN PROGUIDE WAS DISCOVERED AFTER CT SCANNING WHEN MEASURING THE REFERENCE DISTANCE BEFORE TREATMENT PLANNING. THE NEEDLE WAS REMOVED AND THE BROKEN FRAGMENT OF THE PROGUIDE NEEDLE REMAINED IN THE PATIENT. THE FACILITY INDICATED THAT THERE WAS NO PATIENT EFFECT RESULTING FROM THE EMBEDDED FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36151 ONCOSMART PROGUIDE NEEDLE HDR REMOTE AFTERLOADER ACCESSORY JAQ NUCLETRON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other