BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS KIT 10 G DIAM TIP SIDE-OPEN DOUBL

    MDR report key: 3132661 · Received May 29, 2013

    Report

    Report Number
    2520274-2013-02866
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CLASSIFICATION CODES: FZX, HXG, HTW, MJG. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON (B)(6) 2013, THE SURGEON USED A SYNFLATE MEDIUM BALLOON. THE SURGEON ATTEMPTED TO INSERT A SECOND BALLOON BUT IT WAS NOT POSSIBLE. THE SURGEON STATED THAT THE DIAMETER OF THE ACCESS NEEDLE IS WAY TOO SMALL AND THAT THIS IS A DESIGN ERROR. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236476 ACCESS KIT 10 G DIAM TIP SIDE-OPEN DOUBL NDN SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1