BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACUT

    MDR report key: 24770254 · Received April 2, 2026

    Report

    Report Number
    2124215-2026-18269
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    May 13, 2025
    Report Date
    April 2, 2026
    Manufacturer
    LUMENIS LTD
    Product Code
    GCJ
    PMA / PMN Number
    K050639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. GIULIONI, C., TALLE, M., PAPAVERI, A., MENGONI, F., ORCIANI, R., PANDOLFO, S. D., IMBIMBO, C., CROCETTO, F., MAURIZI, V., GAUHAR, V., & CAFARELLI, A. (2025). THE IMPLEMENTATION OF TRIFECTA SCORE TO ASSESS THE QUALITY OF HOLMIUM LASER ENUCLEATION OF THE PROSTATE IN ELDERLY PATIENTS: AN ANALYSIS OF PERIOPERATIVE AND FUNCTIONAL OUTCOMES AND THE IMPACT OF AGE. JOURNAL OF CLINICAL MEDICINE, 14(10), 3410. HTTPS://DOI.ORG/10.3390/JCM14103410.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A LITERATURE ARTICLE PUBLISHED IN THE JOURNAL OF CLINICAL MEDICINE THAT A RETROSPECTIVE ANALYSIS EVALUATED THE EFFICACY AND SAFETY OF HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) IN 981 PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA TREATED BETWEEN JANUARY 2016 AND DECEMBER 2022 AT A SINGLE INSTITUTION. ALL PROCEDURES WERE PERFORMED USING A 120W HOLMIUM LASER MANUFACTURED BY LUMENIS WITH A 550NM REUSABLE LASER FIBER. A VERSACUT MORCELLATOR WAS ALSO USED TO REMOVE THE PROSTATE TISSUES. PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON AGE (ABOVE OR EQUAL OF 75 YEARS AND BELOW 75 YEARS) TO ASSESS SURGICAL OUTCOMES USING THE TRIFECTA SCORE, DEFINED AS POSTOPERATIVE QMAX HIGHER THAN 15 ML/S, IPSS LOWER THAN 8, AND ABSENCE OF PERIOPERATIVE COMPLICATIONS. BOTH GROUPS DEMONSTRATED SIGNIFICANT IMPROVEMENT IN URINARY SYMPTOMS AND FLOW PARAMETERS FOLLOWING THE PROCEDURE. AT THE THREE-MONTH FOLLOW-UP, ELDERLY PATIENTS SHOWED SLIGHTLY HIGHER SYMPTOM SCORES AND LOWER URINARY FLOW RATES; HOWEVER, BY ONE YEAR THE FUNCTIONAL OUTCOMES WERE COMPARABLE BETWEEN AGE GROUPS. THE TRIFECTA SCORE ACHIEVEMENT RATE WAS 63.5% IN ELDERLY PATIENTS AND 68.8% IN YOUNGER PATIENTS WITH NO STATISTICALLY SIGNIFICANT DIFFERENCE. REPORTED EARLY COMPLICATIONS CONSISTED OF 31 PATIENTS WITH URINARY TRACT INFECTION, 37 PATIENTS WITH ACUTE URINARY RETENTION, 34 PATIENTS REQUIRED BLOOD TRANSFUSION, 9 PATIENTS HAD POSTOPERATIVE BLEEDING WHICH NEEDED ENDOSCOPIC HEMOSTASIS, AND 4 RARE CASES OF SEPSIS NEEDING ADMISSION TO THE INTENSIVE CARE UNIT. LATE COMPLICATIONS CONSISTED OF 28 PATIENTS WITH BULBAR URETHRAL STRICTURE REQUIRING OUTPATIENT DILATATION, 24 PATIENTS WITH URETHRAL STRICTURE NECESSITATING URETHROTOMY UNDER ANESTHESIA, 37 PATIENTS WITH BLADDER NECK SCLEROSIS REQUIRING TRANSURETHRAL INCISION, AND 9 PATIENTS WHO UNDERWENT REPEATED SURGERY FOR BPH WITHIN 1-YEAR. ADDITIONALLY, URINARY INCONTINENCE RATES FOLLOWING THE PROCEDURE WERE ALSO DOCUMENTED. ONE MONTH POSTOPERATIVELY, 37 PATIENTS EXPERIENCED URGE INCONTINENCE, 85 PATIENTS EXPERIENCED STRESS INCONTINENCE, AND 23 PATIENTS EXPERIENCED MIXED INCONTINENCE. ONE YEAR POSTOPERATIVELY, 5 PATIENTS EXPERIENCED URGE INCONTINENCE, 54 PATIENTS EXPERIENCED STRESS INCONTINENCE, AND 8 PATIENTS EXPERIENCED MIXED INCONTINENCE. THE AUTHORS CONCLUDED THAT HOLEP IS A SAFE AND EFFECTIVE SURGICAL TREATMENT FOR BENIGN PROSTATIC HYPERPLASIA IN ELDERLY PATIENTS, WITH OUTCOMES COMPARABLE TO YOUNGER COHORTS AFTER ONE YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824625 VERSACUT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ LUMENIS LTD UNK-P-VERSACUT_MORCELLATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H