BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 EASYPACK PATIENT INTERFACE

    MDR report key: 21514910 · Received March 4, 2025

    Report

    Report Number
    3003288808-2025-00055
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 13, 2026
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K190392
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE REPORTED PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORTED PRODUCT WAS NOT RECEIVED AT THE PRODUCTION SITE AND INSUFFICIENT INFORMATION WAS PROVIDED. THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. RETURNED PRODUCT WAS RECEIVED AT MANUFACTURE SITE. VISUAL INSPECTION OF THE APPLANATION CONE WITH A PHOTOMICROSCOPE SHOWS DEBRIS AND DRIED LIQUID ON THE APPLANATION SURFACE. IT IS UNCLEAR WHETHER THERE WERE DEBRIS ON THE APPLANATION SURFACE BEFORE DOCKING PROCEDURE OR ONLY AFTER DOCKING. THE MOST POSSIBLE ROOT CAUSE FOR DEBRIS IS FALL OUT OF PARTICLES DURING TRANSPORTATION FROM CUSTOMER TO MANUFACTURER AS PATIENT INTERFACE WAS NOT ORIGINALLY CLOSED. FUNCTIONAL INSPECTION OF THE PATIENT INTERFACE ON THE FEMTOSECOND SHOWS NO DEVIATION DURING DETECTION AND FOCUS CONTROL OF THE PATIENT INTERFACE. THE CONE HAS SUCCESSFULLY PASSED THE CALIBRATION CHECK. THE DOCKING OF THE PATIENT INTERFACE ON A RUBBER TEST EYE WAS PERFORMED WITHOUT ISSUE AND A TREATMENT WOULD BE POSSIBLE. THE DOCKING PROCESS WAS RETRIED SEVERAL TIMES AND WITH TWO ORIENTATIONS OF THE SUCTION RING BUT NO LACK OF SUCTION OR INSTABLE SUCTION COULD BE REPRODUCED. LOGFILES HAVE BEEN REQUESTED BUT HAVE NOT ARRIVED. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BECAUSE THE REPORTED EVENT COULD NOT BE REPRODUCED DURING INVESTIGATION. THERE IS NO INDICATION THAT A PRODUCT MALFUNCTION COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

    Description of Event or Problem · 0

    A NURSE REPORTED PATIENT INTERFACE WAS DAMAGED AND UNABLE TO GET SUCTION IN THE UNKNOWN EYE OF THE PATIENT DURING LASIK SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77453 WAVELIGHT FS200 EASYPACK PATIENT INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH 1515 16CPJR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown