BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FERREIRA BREAST RETRACTOR W/FIBER OPTICS

    MDR report key: 5077607 · Received September 15, 2015

    Report

    Report Number
    2523190-2015-00092
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Report Date
    August 24, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    10/14/15 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - BREAST RETRACTOR RETURNED NOT SHOWING ANY UNUSUAL MARKINGS. THE BREAST RETRACTOR RETURNED IN USED CONDITION WITH SCRATCHES. THERE IS DISCOLORATION ON THE HANDLE. THIS TYPE OF DAMAGE IS TYPICALLY THE RESULT OF IMPROPER PROCESSING. DEVICE HISTORY EVALUATION - DHR COMPLETED WITH ALL AVAILABLE HISTORY. NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE GOLD FINISH IS WORN ON THE HANDLE OF THE RETRACTOR. WITH OUT KNOWING THE LIGHT SOURCE; ARE UNABLE TO REPRODUCE COMPLAINT. THE COMPLAINT HAS BEEN UNCONFIRMED; COULD NOT DUPLICATE REPORTED INCIDENT.

    Description of Event or Problem · 1

    DEALER REPORTS THE DOCTOR WAS HAVING ISSUES WITH THE HANDLE BECOMING TOO HOT TO HOLD. NO HARM DONE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609559 FERREIRA BREAST RETRACTOR W/FIBER OPTICS FIBER OPTIC INSTRUMENTATION GAD INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1