BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLIBRI

    MDR report key: 4172395 · Received October 15, 2014

    Report

    Report Number
    8030965-2014-01598
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    October 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE CONTROL UNIT IS NOT FUNCTIONING AND THE TRIGGER WAS JAMMED. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR SERVICE WITH THE COMPLAINT THAT "THE LOWER EASY BUTTON STAYS INSIDE AND CLAMPS." THIS IS REPORT 1 OF 1 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654705 COLIBRI MOQ SYNTHES GMBH 568

    Patients

    Seq Age Sex Outcome Treatment
    1