BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY, REPLACEMENT, RECHARGEABLE

    MDR report key: 4141481 · Received October 4, 2014

    Report

    Report Number
    2520274-2014-13890
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN COLIBRI 1 OR 2, PART/LOT NUMBER UNKNOWN . WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE MTA WARD HAD RECEIVED A REIDAR REPORT. (B)(4), THE REPORT IS ABOUT A COLIBRI THAT HAVE BEEN ON SERVICE BECAUSE THE MASKIN BUTTON GOT STUCK AND DIDN´T STOP DRILLING WHEN THE SURGEON RELEASE THE START BUTTON. ACCORDING TO THE REPORT, THE EVENT HAPPENED DURING SURGERY. THERE WAS NO PATIENT HARM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621692 BATTERY, REPLACEMENT, RECHARGEABLE MOQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1