BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUCHANAN PLUGGER

    MDR report key: 1286186 · Received January 13, 2009

    Report

    Report Number
    2016150-2009-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2009
    Date of Event
    December 1, 2008
    Report Date
    December 17, 2008
    Manufacturer
    SYBRONENDO
    Product Code
    EKR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO INJURIES DUE TO THE REPORTED INCIDENT; HOWEVER THIS INCIDENT IS REPORTABLE SINCE THE DOCTOR ALLEGED THAT THE MALFUNCTION COULD HAVE CAUSED A SERIOUS INJURY TO THE PATIENT. THE PRODUCT WAS RETURNED TO SYBRONENDO FOR EVALUATION. THE EVALUATION OF THE RETURNED PRODUCT INDICATED THAT THE ALLEGED FAILURE COULD NOT BE DUPLICATED. ACCORDING TO THE RISK ASSESSMENT OF THE PRODUCT IF OVERHEATING OF THE TIP OCCURS, THE CONDITION WOULD BECOME OBVIOUS TO THE USER WHO COULD DEACTIVATE THE UNIT IMMEDIATELY TO STOP THE HEAT BEFORE ANY INJURY COULD OCCUR TO THE PATIENT. NO FURTHER ACTION IS REQUIRED. THIS IS THE FINAL REPORT. (B) (4).

    Description of Event or Problem · 1

    ON DECEMBER 17, 2008, A DOCTOR REPORTED TO SYBRONENDO THAT A BUCHANAN PLUGGER OVERHEATED DURING A PATIENT¿S ROOT CANAL PROCEDURE. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUCHANAN PLUGGER PLUGGER, ROOT CANAL, ENDODONTIC EKR SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1