BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED LASER SURGICAL INSTRUMENT

    MDR report key: 22145103 · Received June 4, 2025

    Report

    Report Number
    2124215-2025-35545
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    June 21, 2024
    Report Date
    September 19, 2025
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WANG Y, WANG J, SUN X. THE EFFECT OF HIGH AND LOW POWER HOLMIUM LASER SETTINGS FOR TRANSURETHRAL LITHOTRIPSY IN THE MANAGEMENT OF ADULTS WITH URETERAL STONE. J PHYSIOL INVEST 2024; 67:153 60.

    Additional Manufacturer Narrative · 0

    B2 OUTCOMES ATTRIB TO ADV EVENT: CORRECTION B3. DATE OF EVENT: EXACT EVENT DATE IS UNKNOWN. DATE OF PUBLICATION USED. WANG Y, WANG J, SUN X. THE EFFECT OF HIGH AND LOW POWER HOLMIUM LASER SETTINGS FOR TRANSURETHRAL LITHOTRIPSY IN THE MANAGEMENT OF ADULTS WITH URETERAL STONE. J PHYSIOL INVEST 2024;67:153 60. 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. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH USE OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC WAS INFORMED VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF PHYSIOLOGICAL INVESTIGATION THAT A PROSPECTIVE, SINGLE-CENTER STUDY WAS CONDUCTED TO EVALUATE THE THERAPEUTIC EFFICACY OF DIFFERENT HOLMIUM LASER POWER SETTINGS IN THE TREATMENT OF URETERAL STONES. THE STUDY ALSO AIMED TO ASSESS THE RELATIONSHIP BETWEEN COMPUTED TOMOGRAPHY (CT) FINDINGS AND TREATMENT OUTCOMES. A TOTAL OF 207 PATIENTS WITH SINGLE, PRIMARY URETERAL STONES WERE ENROLLED BETWEEN JANUARY 2019 AND DECEMBER 2021. PATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE EITHER LOW-POWER (LP, UP TO 20 W) OR HIGH-POWER (HP, UP TO 100 W) HOLMIUM:YAG LASER LITHOTRIPSY. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA BY A SINGLE EXPERIENCED UROLOGIST USING FLEX XC, FLEX X2S, OR URF P7 FLEXIBLE URETEROSCOPES AND A 120 W HO:YAG LASER WITH A 200 UM FIBER (LUMENIS INC.). SURGICAL EFFICIENCY, URINARY SYMPTOMS, AND QUALITY OF LIFE WERE ASSESSED USING OPERATIVE TIME, THE INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), THE OVERACTIVE BLADDER SYMPTOM SCORE (OABSS), AND QOL SCORES. PERIOPERATIVE COMPLICATIONS INCLUDED 27 CASES OF URINARY TRACT INFECTION (UTI) AND 23 CASES OF EPIDIDYMITIS. POSTOPERATIVE COMPLICATIONS INCLUDED 8 CASES OF HEMATURIA, 6 CASES OF FEVER, 9 CASES OF UTI, AND 11 CASES OF URINARY RETENTION REQUIRING RE-CATHETERIZATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC WAS INFORMED VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF PHYSIOLOGICAL INVESTIGATION THAT A PROSPECTIVE, SINGLE-CENTER STUDY WAS CONDUCTED TO EVALUATE THE THERAPEUTIC EFFICACY OF DIFFERENT HOLMIUM LASER POWER SETTINGS IN THE TREATMENT OF URETERAL STONES. THE STUDY ALSO AIMED TO ASSESS THE RELATIONSHIP BETWEEN COMPUTED TOMOGRAPHY (CT) FINDINGS AND TREATMENT OUTCOMES. A TOTAL OF 207 PATIENTS WITH SINGLE, PRIMARY URETERAL STONES WERE ENROLLED BETWEEN JANUARY 2019 AND DECEMBER 2021. PATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE EITHER LOW-POWER (LP, UP TO 20 W) OR HIGH-POWER (HP, UP TO 100 W) HOLMIUM:YAG LASER LITHOTRIPSY. ALL PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA BY A SINGLE EXPERIENCED UROLOGIST USING FLEX XC, FLEX X2S, OR URF P7 FLEXIBLE URETEROSCOPES AND A 120 W HO:YAG LASER WITH A 200 UM FIBER (LUMENIS INC.). SURGICAL EFFICIENCY, URINARY SYMPTOMS, AND QUALITY OF LIFE WERE ASSESSED USING OPERATIVE TIME, THE INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS), THE OVERACTIVE BLADDER SYMPTOM SCORE (OABSS), AND QOL SCORES. PERIOPERATIVE COMPLICATIONS INCLUDED 27 CASES OF URINARY TRACT INFECTION (UTI) AND 23 CASES OF EPIDIDYMITIS. POSTOPERATIVE COMPLICATIONS INCLUDED 8 CASES OF HEMATURIA, 6 CASES OF FEVER, 9 CASES OF UTI, AND 11 CASES OF URINARY RETENTION REQUIRING RE-CATHETERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874624 POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other