BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC PEN DRIVE 60,000 RPM

    MDR report key: 2220182 · Received August 16, 2011

    Report

    Report Number
    8030965-2011-00549
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 22, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    DZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS POWER EQUIPMENT AND IS NOT IMPLANTED OR EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATES A CLINIC, (B)(6) REPORTED: DURING A LONG PROCEDURE, TWO ELECTRIC PEN DRIVES TURNED THEMSELVES ON AT VARIUS TIMES W/O ANYONE TURNING THEM ON. THE CONSULTANT DOES NOT KNOW IF THE TWO STANDARD CONSOLES W/IRRIGATION OR THE PEN DRIVES WERE AT FAULT. IT WAS NOTED NO DAMAGE WAS DONE AND NO ONE WAS INJURED. BOTH SETS ARE UNDER INVESTIGATION. THIS IS ONE OF FOUR REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRIC PEN DRIVE 60,000 RPM ELECTRIC PEN DRIVE DZI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONSOLE.| CONSOLE