BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE 1375011 ESSAR REPLACEMENT

    MDR report key: 6035284 · Received October 17, 2016

    Report

    Report Number
    2523190-2016-00177
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Report Date
    September 2, 2016
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    ON 9/29/2016 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - FAILURE ANALYSIS CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED. .UNCONFIRMED/NO RETURN OF DEVICE FOR EVALUATION. DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY/CORRECTIONS: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    HAVING ISSUES WITH INTEGRA ENT ESSAR SUCTION IRRIGATION. SPECIFICALLY THE SILICONE VALVES ARE LEAKING. SILICONE BREAKING DOWN EXTREMELY FAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684339 VALVE 1375011 ESSAR REPLACEMENT PFM11 KCB INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1