BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE PROBE WITH BLOCKING WASHER

    MDR report key: 2475679 · Received January 31, 2012

    Report

    Report Number
    1124791-2006-00009
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    August 19, 2006
    Report Date
    August 19, 2006
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    JAQ
    PMA / PMN Number
    033371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME CIRCUMSTANCES, IT IS POSSIBLE FOR THE OLD DESIGN BLOCKING WASHER TO SHIFT TO A DIFFERENT POSITION ON THE FLEXIBLE PROBE, OR DESTABILIZE IT TO THE EXTENT THAT IT DOES NOT SECURE THE PROBE TO THE SOURCE GUIDING TUBE WHEN THE LOCKING NUT IS TIGHTENED. THE SHIFTS REPORTED FOR THE OLD DESIGN HAVE BEEN IN THE DISTAL DIRECTION ALONG THE PROBE CAUSING THE TIP OF THE PROBE TO FALL SHORT OF THE TIP OF THE CYLINDER SEGMENT LUMEN. IF THE SHIFT IS SUFFICIENT TO DISPLACE THE PROBE BELOW THE GRIPPING JAW (APPROX 5MM), THE LOCKING MECHANISM WILL NOT WORK, AND THE FLEXIBLE PROBE TIP WILL BE LOCATED PROXIMAL TO THE INTENDED POSITION BY THE DISTANCE OF THE SHIFTED BLOCKING WASHER. VARIAN DEVELOPED A NEW DESIGN FLEXIBLE PROBE AND SOURCE GUIDING TUBE THAT DO NOT CONTAIN A BLOCKING WASHER. THE PARTS FOR THE NEW DESIGN ARE IDENTIFIED AS FOLLOWS, AND HAVE BEEN INCLUDED IN ALL DEFAULT APPLICATOR SETS BEGINNING IN (B)(6) 2010: GM11002280, FLEXIBLE PROBE, 2.8MM X 320 MM AND GM11010280 GUIDING TUBE FOR SEGMENTED CYLINDERS. AN URGENT MEDICAL DEVICE CORRECTION NOTIFICATION LETTER WAS SENT ON (B)(6) 2011. NO ADD'L F/U TO THIS MDR IS EXPECTED. (B)(4). ADD'L LOT #: G08.

    Description of Event or Problem · 1

    TWO FLEXIBLE PROBES WERE RETURNED BY THE CUSTOMER WITH BLOCKING WASHERS THAT HAD SLIPPED. INITIAL INVESTIGATION BY TECHNICAL SERVICE SUGGESTED THAT THE WASHER MAY HAVE BROKEN FREE DURING DISASSEMBLY - IF THE LOCKING NUT WAS PULLED TOWARD THE TIP OF THE FLEXIBLE PROBE, WHILE TWISTING THE FLEXIBLE PROBE. THIS MAY HAVE OCCURRED IF THE USER WAS NOT AWARE THAT THE LOCKING NUT WAS REMOVABLE ONLY TOWARD THE BOTTOM OF THE FLEXIBLE PROBE, AND WAS FIXED IN PLACE AFTER DETHREADING FROM THE TANDEM. VARIAN HAS SINCE DETERMINED IN 2011 THERE WAS A PRODUCT PROBLEM WITH THE DESIGN OF THE FLEXIBLE PROBES WITH BLOCKING WASHER, PART NUMBER GM11002420, AND HAS RECALLED THE PRODUCT. ALL PREVIOUS COMPLAINTS OF A MOVED BLOCKING WASHER ARE BEING REPORTED AS MDRS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE PROBE WITH BLOCKING WASHER BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS GM1102420/11005090 F51

    Patients

    Seq Age Sex Outcome Treatment
    1