BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BROWN-ADSN FCPS 4-3/4 7X7

    MDR report key: 6789059 · Received August 11, 2017

    Report

    Report Number
    2523190-2017-00083
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    June 20, 2017
    Report Date
    July 14, 2017
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 8/7/2017 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 FOR EVALUATION. UNCONFIRMED. 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

    CUSTOMER MW 5070582 REPORTS A PATIENT IN OPERATING ROOM FOR PARTIAL LEFT PARTIAL LEFT 2ND DIGIT AMPUTATION. AFTER THE PROCEDURE CENTRAL STERILE PERSONNEL WERE CLEANING THE INSTRUMENT AND NOTICED ONE TOOTH OF THE MILTEX #6-124 BROWN-ADSON TISSUE FORCEPS WAS MISSING. A POST OP X_RAY HAD ALREADY BEEN TAKEN. NO RADIOPAQUE FOREIGN BODIES WERE SEEN. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568765 BROWN-ADSN FCPS 4-3/4 7X7 M5 - GENERAL SURGERY GEN INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1