BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDESAFE HANDPIECE

    MDR report key: 2572894 · Received May 9, 2012

    Report

    Report Number
    2428235-2012-00008
    Event Type
    Malfunction
    Date Received
    May 9, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K102698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS OPENED AND THE INTERNAL ELECTRONICS INSPECTED. THERE WAS A MODERATE AMOUNT OF DEFORMATION OF THE PLASTIC AROUND THE CONTACT POINTS BUT NO PITTING THAT WOULD HAVE BEEN CONSISTENT WITH A FLAME OR PROLONGED EXPOSURE TO EXTREME HEAT. GIVEN THE LOCATION OF THE CHAR ON THE INSIDE OF THE DEVICE AND THE LIMITED CLEARANCE BETWEEN THE MOVABLE ELECTRODE TIP AND THE OUTER CLAMSHELL, THERE IS VIRTUALLY NO CHANCE THAT THERE WERE FLAMES COMING OUT THE DISTAL TIP AS CLAIMED IN THE ORIGINAL CUSTOMER COMPLAINT. MORE LIKELY, THE USER SAW THE EVIDENCE OF THE BRIGHT FLASH RESULTING FROM THE NORMAL SPARKING OF THE INTERNAL CONTACTS THROUGH THE TRANSLUCENT ORANGE PLASTIC AT THE DISTAL TIP AND INTERPRETED THIS AS FLAMES. THE DEVICE FOUND TO BE WORKING WHEN TESTED. THERE WAS NO DANGER OF PT INJURY IN THIS CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT WHEN USER WENT TO USE THE 15MM GLIDESAFE HANDPIECE, FLAMES CAME OUT OF THE TIP. WE WERE ADVISED THAT NO ONE WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDESAFE HANDPIECE GEI ELLMAN INT'L INC. P215HPD 39894

    Patients

    Seq Age Sex Outcome Treatment
    1