BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANMATE A

    MDR report key: 6190161 · Received December 20, 2016

    Report

    Report Number
    2522950-2016-00002
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Report Date
    November 29, 2016
    Manufacturer
    DGH TECHNOLOGY, INC.
    Product Code
    IYO
    UDI-DI
    00857377006094
    PMA / PMN Number
    K093371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/20/2016 ANALYSIS OF EVENTS AND DEVICE FUNCTIONALITY ONGOING. ASSESSMENT OF MEASUREMENT RECORDS PROVIDED TO DGH DOES NOT NECESSARILY INDICATE A PROBLEM WITH THE DEVICE. WITHOUT PRECISE POST-OPERATIVE REFRACTIVE ERROR DATA, IOL CALCULATION REPORTS OR PATIENT IDENTIFICATION INFORMATION, CONCLUSIVE ANALYSIS OF THE EVENT IS NOT POSSIBLE. A COMPARATIVE ANALYSIS OF MEASUREMENT DATA IS BEING ARRANGED BY THE DISTRIBUTOR ((B)(4)).

    Description of Event or Problem · 1

    NOTIFICATION WAS RECEIVED FROM A DISTRIBUTOR ((B)(4)) WHOM DGH HAD SOLD A DEMONSTRATION DGH 6000 A-SCAN DEVICE. THIS DEVICE HAD BEEN PROVIDED BY THE DISTRIBUTOR TO A CUSTOMER FOR TRIAL USE. THIS DEVICE HAD BEEN IN SERVICE AT THE USER'S FACILITY FOR SEVERAL MONTHS (START DATE UNKNOWN), WITH THE TRIAL PERIOD ENDING ON (B)(6) 2016. IT WAS COMMUNICATED BY THE DISTRIBUTOR ((B)(4)) THAT OPERATORS OF THE DEVICE HAD COMPLAINED THAT IT TAKES TOO LONG TO BEGIN MEASUREMENT AND THAT THE READINGS ARE UNSTABLE. THE DISTRIBUTOR ((B)(4)) REQUESTED THAT SUPPORT INFORMATION BE PROVIDED BY DGH TO IMPROVE THE MEASUREMENT ACCURACY OF THE DEVICE. DURING SUBSEQUENT COMMUNICATION WITH THE DISTRIBUTOR, IT WAS REPORTED TO DGH THAT DURING THE TIME THE DGH 6000 WAS IN TRIAL USE, THERE WERE TEN (10) INSTANCES OF PATIENTS SHOWING A POST-OPERATIVE REFRACTIVE ERROR OF +1.50 THROUGH +2.00 DIOPTERS, AND ONE (1) INSTANCE OF A PATIENT SHOWING A POST-OPERATIVE REFRACTIVE ERROR OF +5.00 DIOPTERS. DURING THIS TIME, IT IS ESTIMATED THAT MORE THAN TWO-HUNDRED (200) PATIENTS' EYES RECEIVED SURGERY WITH ACCEPTABLE RESULTS (ACCEPTABLE BEING LESS THAN +1.50 DIOPTER REFRACTIVE ERROR). IT WAS REPORTED THAT THERE WERE NO SUBSEQUENT SURGICAL CORRECTIONS PERFORMED ON ANY OF THE ELEVEN (11) PATIENTS SHOWING HIGH POST-OPERATIVE REFRACTIVE ERRORS. THE DGH 6000 DEVICE IS THOUGHT TO BE CONTRIBUTING TO THE AFOREMENTIONED EVENTS BECAUSE IT IS THE ONLY EQUIPMENT CHANGED IN PREVIOUS MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841474 SCANMATE A ULTRASONIC A-SCAN IYO DGH TECHNOLOGY, INC. DGH 6000 00857377006094

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other