BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-MINIATURE LIGHT WIRE CUTTER

    MDR report key: 2112790 · Received April 29, 2011

    Report

    Report Number
    2086211-2011-00003
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Report Date
    April 1, 2011
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, 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. THE DEVICE WAS RETURNED AND EVALUATED FOR DIMENSIONAL MEASUREMENTS AND CUTTING PERFORMANCE AND FOUND TO BE IN SPECIFICATION. ALSO, A DHR REVIEW WAS CONDUCTED; NO EVIDENCE OF MANUFACTURING ISSUES OR PROCESS DEVIATIONS WAS IDENTIFIED.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT THE TIP OF A MICRO-MINIATURE LIGHT WIRE CUTTER SEPARATED, RESULTING IN THE PATIENT RECEIVING A SMALL CUT ON THE LIP. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO TREAT THE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO-MINIATURE LIGHT WIRE CUTTER EJB GAC INTERNATIONAL 10-33

    Patients

    Seq Age Sex Outcome Treatment
    1 .012 LIGATURE WIRE