BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY OSCILLATOR II

    MDR report key: 4389259 · Received January 6, 2015

    Report

    Report Number
    3009450871-2014-10924
    Event Type
    Malfunction
    Date Received
    January 6, 2015
    Report Date
    February 12, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: MOQ. (B)(6). A SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE DEVICE HAS BEEN PERFORMED. THE REVIEW INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED DURING THE PAST 6 MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT NO ABNORMALITY ON THE PARTS FOUND, EXCEPT EXCESSIVE GREASE / OIL RESIDUE. NO PARTS WERE DAMAGED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 LOCKING MECHANISM WAS DEFECTIVE. DEVICE FAILED DURING THE OPERATION. A SPARE DEVICE WAS AVAILABLE. OPERATION COULD BE CONTINUED WITHOUT ANY HARM TO THE PATIENT. THERE WAS A 5 MINUTES DELAY IN SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5785 BATTERY OSCILLATOR II MOTOR,SURGICAL INSTRUMENT,AC-POWERED GEY DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1