BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-MINIATURE LIGHT WIRE CUTTER

    MDR report key: 1726676 · Received June 11, 2010

    Report

    Report Number
    2086211-2010-00085
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 13, 2010
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, AND THOUGHT THE EVENT OCCURRED OUTSIDE OF A PATIENT'S MOUTH, THERE HAS BEEN A PREVIOUS REPORT RECEIVED IN THE PAST TWO YEARS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A MICRO-MINIATURE LIGHT WIRE CUTTER BECAME CHIPPED DURING THE STERILIZATION PROCESS; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-MINIATURE LIGHT WIRE CUTTER EJB GAC INTERNATIONAL 09-36

    Patients

    Seq Age Sex Outcome Treatment
    1 .012 LIGATURE TIES