BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDE EXTENSION EPOCA RIGID W/QUICK-COUP

    MDR report key: 2961951 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-00461
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    November 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS REPORT IS FOR TWO PARTS THAT HAVE THE SAME PART/LOT NUMBERS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: CUSTOMER FACILITY REPORTED THAT GUIDE EXTENSIONS ARE LOOSE. IT IS REPORTED THAT AFTER 5-6 OPERATIONS, THE GUIDE EXTENSIONS BECAME LOOSE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65078 GUIDE EXTENSION EPOCA RIGID W/QUICK-COUP GUIDE EXTENSION EPOCA KWQ SYNTHES GMBH T973357

    Patients

    Seq Age Sex Outcome Treatment
    1