BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 16529030 · Received March 13, 2023

    Report

    Report Number
    3003288808-2023-00076
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    February 9, 2023
    Report Date
    June 2, 2023
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE REVIEW OF LOGFILE 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 NOT PERFORMED AS RECOMMENDED EVERY TWO HOURS. LOGFILE SHOWS FOUR SUCCESSFULLY PERFORMED TREATMENTS. THE REPORTED TREATMENT COULD NOT BE IDENTIFIED IN THE LOGFILE DUE TO MISSING TREATMENT REPORTS. LOG FILE SHOWS THAT TWO PATIENTS WERE TREATED ON THE REPORTED TREATMENT DAY, EACH RIGHT AND LEFT EYE. TREATMENTS FOR FIRST PATIENT'S RIGHT AND LEFT EYE WAS ABORTED DURING BED CUT FROM SURGEON BY PRESSING THE FOOT PEDAL AND WAS SUBSEQUENTLY CANCELLED. AFTER THAT, TREATMENTS FOR FIRST PATIENT RIGHT AND LEFT EYE WERE REPEATED AND SUCCESSFULLY COMPLETED. DURING THE BEAM CONTROL CHECK (BCC), PRIOR TO THE PROCEDURE OF THE SECOND PATIENTS LEFT EYE, THE FOLLOWING ERROR MESSAGE OCCURRED TWO TIMES AND TREATMENTS WERE CANCELLED BEFORE FIRING. AFTERWARDS, BEAM CONTROL CHECK (BCC) COULD BE PASSED BUT THE SECOND PATIENTS LEFT EYE WAS ABORTED DURING CANAL CUT FROM SURGEON BY PRESSING THE FOOT PEDAL AND WAS SUBSEQUENTLY CANCELLED. AFTER THAT, TREATMENT FOR SECOND PATIENT LEFT EYE WAS REPEATED AND SUCCESSFULLY COMPLETED. NO RELEVANT DEVIATION BETWEEN PLANNED AND PERFORMED ENERGY IS DETECTABLE FOR PERFORMED TREATMENTS ON EVENT DAY. NO TECHNICAL ROOT CAUSE COULD BE IDENTIFIED DURING LOGFILE REVIEW. A ROOT CAUSE FOR THE CUSTOMER¿S REPORTED EVENT COULD NOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW HEMOPRO 2 CO2 LINE WAS CONNECTED TO THE AIR SUPPLY TUBE OF THE BTT PORT AND AIR SUPPLY WAS STARTED, BUT AIR SUPPLY WAS NOT POSSIBLE; CO# WAS NOT EXHAUSTED FROM THE BTT PORT. BTT PORT USED 20CC AIR. FLOW RATE: 4, PRESSURE: 11 MMHG. THE PATIENT WAS REPLACED WITH A NEW VH-4000 (BTT PORT), AND INSUFFLATION BECAME POSSIBLE, SO THE OPERATION WAS CONTINUED. THERE WAS NO LENGTHENING OF THE OPERATION OR HARM TO THE PATIENT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515146 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA NA 00380659909412

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female WAVELIGHT FS200 EASYPACK PATIENT INTERFACE