BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILAT Ø10/13 F/03.610.001

    MDR report key: 2884595 · Received December 23, 2012

    Report

    Report Number
    8030965-2012-01661
    Event Type
    Malfunction
    Date Received
    December 23, 2012
    Report Date
    November 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE COMPLAINED INSTRUMENTS WERE INVESTIGATED BASED TO THE MATERIAL AND MANUFACTURING DOCUMENTS, THE INVESTIGATION HAS SHOWN THAT THE INSTRUMENTS WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. BASED ON THIS RESULT, NO PRODUCT FAULT COULD BE DETECTED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF FAILURE IN RETROSPECT AND WITHOUT FURTHER INFORMATION, WE CAN ONLY ASSUME THAT THE FAILURE HAPPENED DUE TO IMPROPER HANDLING.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE MATERIAL IS DAMAGED AT THE DISCHARGE HOLES OF THE DILATORS AND CANNOT BE PUSHED TOGETHER IN COMBINATION WITH BLOOD. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DILAT Ø10/13 F/03.610.001 DILATOR MNI SYNTHES GMBH 7544089

    Patients

    Seq Age Sex Outcome Treatment
    1 DILATOR