BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSES

    MDR report key: 22099431 · Received May 28, 2025

    Report

    Report Number
    2124215-2025-32523
    Event Type
    Injury
    Date Received
    May 28, 2025
    Date of Event
    January 1, 2021
    Report Date
    May 28, 2025
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT: EXACT EVENT DATE IS UNKNOWN. EVENT DATE OF WHEN STUDY STARTED WAS USED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CITATION: FRIEDRICH, O. H., LUISA, E., BRITTA, G., MAREN, J. W., KARL, F. K., PAUL, P., MARIE-CLAIRE, R. S., MAURICE, S. M., JONAS, H. (2024). PULSE MODULATION IN EN BLOC HOLEP: DOES IT REALLY MATTER? A PROPENSITY SCORE MATCHED ANALYSIS. WORLD JOURNAL OF UROLOGY 42(154), 7.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A PROSPECTIVE STUDY WAS CONDUCTED IN ORDER TO EXAMINE THE IMPACT OF MOSES TECHNOLOGY IN HOLEP ON PERIOPERATIVE OUTCOMES AND COMPLICATIONS IN A LARGE REAL-LIFE COHORT OF A SINGLE HIGH-VOLUME SURGEON. THE STUDY OCCURRED WITH 234 PATIENTS UNDER ONE SURGEON FROM JANUARY 2021 TO MARCH 2023. 117 PATIENTS WHO UNDERWENT A MOSES LASER ENUCLEATION OF THE PROSTATE (MOLEP) WERE COMPARED TO 117 PATIENTS WHO UNDERWENT A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP). THE PROCEDURES WERE PERFORMED WITH THE PULSE 120 MOSES HOLMIUM LASER, WITH SLIMLINE 550 SINGLE OR REUSABLE FIBERS, OR WITH MOSES 550 SINGLE FIBERS. IN TERMS OF COMPLICATIONS, NO SIGNIFICANT DIFFERENCES WERE OBSERVED REGARDING POSTOPERATIVE URINARY RETENTION, TRANSFUSION RATE, AND REINTERVENTION RATE. IT WAS MENTIONED THAT PATIENTS EXPERIENCED BLOOD LOSS, URINARY RETENTION, TRANSFUSION, REINTERVENTION. BLEEDING THAT REQUIRED INTERVENTION IN THE FORM OF TRANSURETHRAL COAGULATION WAS SEEN IN 3 PATIENTS. NO TRANSFUSIONS WERE ADMINISTERED. TWO PATIENTS HAD DIFFICULTY IN RECATHETERIZATION AFTER URINARY RETENTION DUE TO BLOOD CLOTS IN THE PROSTATIC FOSSA, WHICH WAS RESOLVED BY FLEXIBLE CYSTOSCOPY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THIS COMPLAINT IS FOR THE MOSES FIBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358060 MOSES POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-MOSES_FIBERS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other P120, MOSES PULSE.