BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAINLESS STEEL NEEDLE 200MM, 17 GAUGE, TROCAR

    MDR report key: 1911526 · Received November 24, 2010

    Report

    Report Number
    9612638-2010-00005
    Event Type
    Other
    Date Received
    November 24, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 23, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K073133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE REMAINS UNDER INVESTIGATION. THE AFFECTED PART HAS BEEN RETURNED TO THE ORIGINAL MFR FOR ROOT CAUSE ANALYSIS. AT THIS TIME, THERE IS NO INDICATION THAT PART HAD ANY DEFECT.

    Description of Event or Problem · 1

    USER SITE REPORTED THAT THE TIP OF THE (B)(4) NEEDLE 200MM, 17 GAUGE, TROCAR POINT WAS FOUND TO BE MISSING WHEN THEY WERE CLEANING THE PART AFTER USE. THE NEEDLE ISSUED IN CONJUNCTION WITH A PROSTATE TEMPLATE FOR A BRACHYTHERAPY TREATMENT. INVESTIGATION INTO THE CAUSE OF THE TIP DETACHMENT IS ONGOING AT THIS TIME AND THE NEEDLE HAS BEEN RETURNED TO THE ORIGINAL MFR FOR EVAL. THERE WAS NO INJURY TO THE PT. THE PT WAS TREATED AS PRESCRIBED AND THERE WAS NO INDICATION OF A NEEDLE PROBLEM DURING THE PT TREATMENT. THE USER SITE PERFORMED AN X-RAY ON THE PT AND DID NOT FIND THE NEEDLE TIP INSIDE. THE SOURCE GUIDE TUBES WHICH CONNECT THE AFTERLOADER TO THE NEEDLE WERE INSPECTED BY THE USER SITE AND FOUND TO BE FREE OF BODY FLUID. THE USER CONFIRMED ALL SOURCE GUIDE TUBES ARE CLEAN AND FREE OF ANY CONTAMINATION. IT IS BELIEVED THE NEEDLE TIP CAME OFF DUE TO ROUGH HANDLING DURING DISASSEMBLY OF THE NEEDLE FROM THE TEMPLATE OR DURING THE CLEANING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAINLESS STEEL NEEDLE 200MM, 17 GAUGE, TROCAR BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC. GM11009510 H12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other