BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSES PULSE

    MDR report key: 22149360 · Received June 5, 2025

    Report

    Report Number
    2124215-2025-35643
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    January 1, 2024
    Report Date
    August 27, 2025
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN ADDITIONAL 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. BLOCK G2: LITERATURE VERGAMINI, L. B., ITO, W., CHOI, N., DU, H. E., SARDIU, M. E., NEFF, D., DUCHENE, D. A., MOLINA, W. R., & WHILES, B. B. (2024). HOLMIUM: YTTRIUM-ALUMINIUM-GARNET LASER WITH MOSES TECHNOLOGY IS MORE EFFICIENT THAN THULIUM FIBRE LASER IN SUPINE MINI-PERCUTANEOUS NEPHROLITHOTOMY. BJU INTERNATIONAL, 134(2), 276 - 282. HTTPS://DOI.ORG/10.1111/BJU.16392.

    Additional Manufacturer Narrative · 0

    BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED PERFORMANCE ALLEGATION IN THIS COMPLAINT HAS NOT BEEN CONFIRMED, AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. WITHOUT A RETURNED DEVICE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS OF HEMATOMA AND LACERATION ARE A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICES AS INDICATED IN THE INSTRUCTIONS FOR USE. ACCORDING TO THIS INFORMATION, A PROBABLE CAUSE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. 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 SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE VERGAMINI, L. B., ITO, W., CHOI, N., DU, H. E., SARDIU, M. E., NEFF, D., DUCHENE, D. A., MOLINA, W. R., & WHILES, B. B. (2024). HOLMIUM:YTTRIUM-ALUMINIUM-GARNET LASER WITH MOSES TECHNOLOGY IS MORE EFFICIENT THAN THULIUM FIBRE LASER IN SUPINE MINI-PERCUTANEOUS NEPHROLITHOTOMY. BJU INTERNATIONAL, 134(2), 276 - 282. HTTPS://DOI.ORG/10.1111/BJU.16392.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE THAT A STUDY WAS CONDUCTED TO DETERMINE THE PAUCITY OF LITERATURE COMPARING OUTCOMES ACHIEVED WITH UTILIZATION OF LUMENIS PULSE P 120HTM WITH MOSES TECHNOLOGY VERSUS THOSE ACHIEVED WITH THE THULIUM FIBER LASER (TFL) IN MINI-PERCUTANEOUS NEPHROLITHOTOMY (PCNL). A RETROSPECTIVE REVIEW WAS PERFORMED OF PATIENTS UNDERGOING SUPINE MINI-PCNL BETWEEN AUGUST 2021 AND MAY 2023. A TOTAL OF 113 PATIENTS MET THE INCLUSION CRITERIA, 51 MINI-PCNLS WITH THE HO: YAG LASER AND 49 WITH THE SOLTIVE SUPER PULSED THULIUM FIBER (SPTF) LASER. NO SIGNIFICANT DIFFERENCES IN DEMOGRAPHICS OR STONE CHARACTERISTICS WERE DETECTED BETWEEN THE TWO GROUPS. THE HO: YAG LASER UTILIZED LESS ENERGY AND TIME, RESULTING IN HIGHER ABLATION EFFICIENCY AND LESS TOTAL OPERATING TIME. OVERALL, THERE WAS NO DIFFERENCE IN STONE-FREE RATE (SFR) IN ANY CATEGORY BETWEEN THE HO: YAG GROUP AND THE SPTF GROUP. ALTHOUGH THE RESEARCHERS OBSERVED AN EQUIVALENT POSTOPERATIVE SFR, THIS STUDY SUPPORTS A SHORTER OPERATING TIME AND GREATER INTRA-OPERATIVE LASER EFFICIENCY WITH THE HO: YAG LASER OVER THE SPTF LASER IN MINI-PCNL. FOLLOWING THE PROCEDURES, THERE WERE COMPLICATION SUCH AS POSTOPERATIVE URETERIC STENT, POSTOPERATIVE NEPHROSTOMY TUBE, URETERIC INJURY, GRADE I AND GRADE II.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE THAT A STUDY WAS CONDUCTED TO DETERMINE THE PAUCITY OF LITERATURE COMPARING OUTCOMES ACHIEVED WITH UTILIZATION OF LUMENIS PULSE P 120HTM WITH MOSES TECHNOLOGY VERSUS THOSE ACHIEVED WITH THE THULIUM FIBER LASER (TFL) IN MINI-PERCUTANEOUS NEPHROLITHOTOMY (PCNL). A RETROSPECTIVE REVIEW WAS PERFORMED OF PATIENTS UNDERGOING SUPINE MINI-PCNL BETWEEN AUGUST 2021 AND MAY 2023. A TOTAL OF 113 PATIENTS MET THE INCLUSION CRITERIA, 51 MINI-PCNLS WITH THE HO:YAG LASER AND 49 WITH THE SOLTIVE SUPER PULSED THULIUM FIBER (SPTF) LASER. NO SIGNIFICANT DIFFERENCES IN DEMOGRAPHICS OR STONE CHARACTERISTICS WERE DETECTED BETWEEN THE TWO GROUPS. THE HO:YAG LASER UTILIZED LESS ENERGY AND TIME, RESULTING IN HIGHER ABLATION EFFICIENCY AND LESS TOTAL OPERATING TIME. OVERALL, THERE WAS NO DIFFERENCE IN STONE-FREE RATE (SFR) IN ANY CATEGORY BETWEEN THE HO:YAG GROUP AND THE SPTF GROUP. ALTHOUGH THE RESEARCHERS OBSERVED AN EQUIVALENT POSTOPERATIVE SFR, THIS STUDY SUPPORTS A SHORTER OPERATING TIME AND GREATER INTRA-OPERATIVE LASER EFFICIENCY WITH THE HO:YAG LASER OVER THE SPTF LASER IN MINI-PCNL. FOLLOWING THE PROCEDURES, THERE WERE COMPLICATION SUCH AS POSTOPERATIVE URETERIC STENT, POSTOPERATIVE NEPHROSTOMY TUBE, URETERIC INJURY, GRADE I AND GRADE II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937835 MOSES PULSE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-P120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention