BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIBLE PROBE WITH BLOCKING WASHER

    MDR report key: 1697356 · Received May 20, 2010

    Report

    Report Number
    9612638-2010-00003
    Event Type
    Other
    Date Received
    May 20, 2010
    Report Date
    May 19, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    JAQ
    PMA / PMN Number
    K033371
    Removal / Correction Number
    9612638-05/19/10-0001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VARIAN MEDICAL SYSTEMS RECEIVED A FLEXIBLE PROBE WITH BLOCKING WASHER BACK FROM A (B)(6) CUSTOMER WITH A SHIFTED BLOCKING WASHER. NO DETAILS ON PATIENT INVOLVEMENT WOULD BE DISCLOSED. IF ANY INJURY WAS ASSOCIATED WITH THIS COMPLAINT IT IS UNKNOWN. THE (B)(6) REPORTED THE INCIDENT TO VARIAN MEDICAL SYSTEMS. A PRODUCT NOTIFICATION LETTER WILL BE DISTRIBUTED TO USERS WHO RECEIVED THE PART PRIOR TO 2004 WITH THE OLDER INSTRUCTION FOR USE. DETAILS ON THE CORRECTIVE ACTIONS ARE REPORTED TO THE FDA (B)(4).

    Description of Event or Problem · 1

    THE INSTRUCTIONS FOR USE (IFU) SENT WITH THE PRODUCT PRIOR TO 2004 INDICATES THE ALLOWED NUMBER OF STERILIZATION CYCLES IS 100. THE CURRENT VERSION OF THE IFU INDICATES THAT THE ALLOWED NUMBER OF STERILIZATION CYCLES IS 25 AND IS THE ACCURATE LIMIT FOR THE FLEXIBLE PROBE WITH A BLOCKING WASHER, (B)(4), USAGE. VARIAN MEDICAL SYSTEMS HAS RECEIVED REPORTS REGARDING MOVEMENT OF THE BLOCKING WASHER ON THE FLEXIBLE PROBE WITH A BLOCKING WASHER, VARIAN PART NUMBER GM11002420, WHICH IS A COMPONENT OF THE SEGMENTED CYLINDER APPLICATOR SET. A FLEXIBLE PROBE WITH AN UNSTABLE OR SHIFTED BLOCKING WASHER MUST NOT BE USED, OR A TREATMENT LENGTH ERROR MAY OCCUR. THE BLOCKING WASHER MAY MOVE FROM ROUGH HANDLING OR STERILIZATION. IT HAS BEEN DETERMINED THAT THE IFU DISTRIBUTED PRIOR TO 2004 LACKS THE LIMIT TO THE STERILIZATION CYCLES AND CHECKS REGARDING THE FIRM SEATING OF THE BLOCKING WASHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE PROBE WITH BLOCKING WASHER BRACHYTHERAPY APPLICATOR JAQ VARIAN MEDICAL SYSTEMS, INC. GM11002420 Y01 TO E19

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART OF THE SEGMENTED CYLINDER SET, GM11004150