BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSAPULSE DUAL 80/100

    MDR report key: 140032 · Received December 19, 1997

    Report

    Report Number
    2914019-1997-00032
    Event Type
    Other
    Date Received
    December 19, 1997
    Date of Event
    November 20, 1997
    Report Date
    November 20, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    BLOCKS THAT WERE BLANK ON INITIAL SUBMISSION HAVE BEEN CORRECTED AS N/A OR WITH THE APPROPRIATE INFORMATION. 8.- INITIAL USE OF DEVICE MEANING FIELD SERVICE ENGINEER TESTED; NO DOCTOR OR CUSTOMER USED DEVICE BEFORE CONFIRMATION OF UNIT CORRECTLY LABELED/WIRED. D.6 - CATALOGUE NUMBER HAS BEEN CORRECTED. A TOTAL OF 6 UNITS THAT WERE INVOLVED HAVE BEEN VERIFIED IN THE FIELD AS CORRECTLY LABELED/WIRED. THE REMAINING 3 UNITS THAT WERE INVOLVED WERE RETURNED TO COHERENT AND TESTED. THESE WERE ALL FOUND TO BE CORRECTLY LABELED/WIRED. ECO TO METHOD TO CLARIFY INSTRUCTIONS HAS BEEN COMPLETED. NOTE: E.1, G.1, AND G.2 HAVE BEEN REVISED AS THE CURRENT ADDRESS AND PHONE NUMBER.

    Description of Event or Problem · 1

    NINE VP SELECT DUAL WAVE LENGTH LASERS MAY HAVE DUAL FOOTSWITCHES THAT ARE INCORRECTLY WIRED (OR PLACED ON INCORRECT SIDE OF LABELING). WHEN YOU SELECT HOLMIUM; ND YAG FIRES, AND WHEN YOU SELECT ND YAG; HOLMIUM FIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE DUAL 80/100 SURGICAL LASER GEX COHERENT MEDICAL LASER GROUP NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA