BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 17774943 · Received September 19, 2023

    Report

    Report Number
    3003288808-2023-00257
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 26, 2023
    Report Date
    January 31, 2024
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    UDI-DI
    00380659909412
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3., H.6.: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: LASER WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE DAY OF THE TREATMENT. PREVENTIVE MAINTENANCE PERFORMED AND SYSTEM MET SPECIFICATIONS AS PER SIR (SERVICE INSTALLATION RECORD). THE REVIEW OF LOG FILE FOR THE DAY OF TREATMENT SHOWS ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS. DURING START-UP OF THE SYSTEM THE VACUUM, THE ENERGY AND THE ABLATION TESTS WERE PERFORMED WITHOUT ANY ISSUE. ENERGY CHECK WAS ONLY PERFORMED DURING START-UP AND NOT AS RECOMMENDED EVERY TWO HOURS. LOG FILE SHOWS THIRTY-ONE SUCCESSFULLY PERFORMED TREATMENTS. THE REPORTED TREATMENT COULD BE IDENTIFIED IN THE LOG FILE. THE THICKNESS OF THE FLAP WAS THINNER THAN THE RECOMMENDED FLAP THICKNESS. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE COULD BE IDENTIFIED AS USER ERROR. THE CANAL WIDTH IS BELOW THE RECOMMENDED VALUES. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE THICKNESS OF THE FLAP WAS INCORRECT IN THE LEFT EYE OF A PATIENT AND THE LASER AT THE EDGE OF THE TUNNEL WAS HIT ON THE PATIENT INTERFACE DURING LASIK SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE PATIENT QY D'S LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986474 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA 143127 00380659909412

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female WAVELIGHT FS200 EASYPACK PATIENT INTERFACE.