BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED LASER SURGICAL INSTRUMENT

    MDR report key: 22403833 · Received July 4, 2025

    Report

    Report Number
    2124215-2025-43481
    Event Type
    Injury
    Date Received
    July 4, 2025
    Date of Event
    February 1, 2025
    Report Date
    July 4, 2025
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FANCELLO, V., DOLCI, C., TANDOI, I., SCHIMBERNI, M., BARTIROMO, L., SALMERI, N., DALESSANDRO, S. (2025). LONG-TERM POSTOPERATIVE RECURRENCE RATES AND FERTILITY OUTCOMES AFTER ENDOMETRIOMA CO2-LASER VAPORIZATION: A FIVE-YEAR FOLLOW-UP EXPERIENCE. THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY 32(2), 171-176. 10.1016/J.JMIG.2024.09.367.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA AN ARTICLE PUBLISHED ON THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY THAT, A RETROSPECTIVE STUDY WAS CONDUCTED TO ASSESS POSTOPERATIVE RECURRENCE RATE AND PREGNANCY RATE IN PATIENTS WITH ENDOMETRIOMAS MANAGED BY CO2 FIBER LASER VAPORIZATION AFTER AT LEAST 5 YEARS FOLLOWING SURGERY. A TOTAL OF 78 PATIENT FROM AN ITALIAN TERTIARY CENTER FROM OCTOBER 2023 TO FEBRUARY 2024 WERE INCLUDED. THE MEAN AGE WAS 33 YEARS. THE CYST WALL WAS VAPORIZED WITH CO2 FIBER LASER (ULTRAPULSE DUO SYSTEM, LUMENIS LTD, YOKNEAM, ISRAEL) IN A RADIAL MANNER, STARTING FROM THE CENTER TO THE PERIPHERY AT A MEAN POWER DENSITY OF 13 W/CM2 (RANGE, 10 15). THE POSTOPERATIVE OUTCOMES INCLUDED HORMONAL THERAPY AFTER SURGERY, IPSILATERAL CYSTS RECURRENCE, RECURRENT ENDOMETRIOMA. CO2 FIBER LASER VAPORIZATION IS AN EFFECTIVE AND SAFE SURGICAL TREATMENT OF OVARIAN ENDOMETRIOMAS, COMBINING THE ADVANTAGE OF BEING AN OVARIAN TISSUE-SPARING TECHNIQUE WITH LONG-TERM POSTOPERATIVE RECURRENCE RATE COMPARABLE WITH THAT DESCRIBED IN LITERATURE FOR THE CYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2763755 POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown