BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 4032043 · Received August 4, 2014

    Report

    Report Number
    3002807715-2014-00004
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    March 28, 2014
    Report Date
    August 4, 2014
    Product Code
    LZS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS SUBMITTED A MEDWATCH FOR SL-1600, WHICH IS A DELIVERY UNIT USED IN CONJUNCTION WITH THE LASER. BUT THE CUSTOMER HAS COMPLAINED ABOUT THE LASER, WHICH HAS STOPPED FIRING. NIDEK INC. TRIED TO CONTACT CUSTOMER TO GET MORE INFORMATION ABOUT THE LASER THE CUSTOMER IS USING IN CONJUNCTION WITH THE SL-1600 (DELIVERY UNIT). NIDEK INC. DID MULTIPLE FOLLOW UPS WITH THE CUSTOMER, BUT COULD NOT GET THE INFORMATION REGARDING THE LASER PRODUCT. ACCORDING TO OUR DATABASE CUSTOMER IS USING LASER ADC-8000, PURCHASED IN 1990 WHICH GOES WITH THE SL-1600. (B)(4).

    Description of Event or Problem · 1

    NIDEK INC. HAS RECEIVED A LETTER FROM FDA FOR A MEDWATCH SUBMITTED BY A CUSTOMER. (B)(4). CUSTOMER REPORTED THE EVENT AS: "EVENT DESCRIPTION: MALE PATIENT WITH PRIMARY OPEN ANGLE GLAUCOMA IN RIGHT EYE UNDERGOING TREATMENT WITH NIDEK LASER. DURING TREATMENT, LASER STOPPED FIRING AND THE PROCEDURE HAD TO BE ABORTED. PATIENT RE-SCHEDULED TO COMPLETE TREATMENT." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455570 UNKNOWN NONE LZS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ADC-8000| SL-1600