BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE

    MDR report key: 20025986 · Received August 22, 2024

    Report

    Report Number
    2124215-2024-51232
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    January 1, 2016
    Report Date
    August 17, 2024
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PIETROPAOLO, A., MASSELLA, V., RIPA, FRANCESCO., SINHA, M. M., & SOMANI, B. K. (2023). URETEROSCOPY AND LASERTRIPSY WITH POP DUSTING USING HIGH POWER HOLMIUM LASER FOR LARGE URINARY STONES > 15 MM: 6.5-YEAR PROSPECTIVE OUTCOMES FROM A HIGH-VOLUME STONE CENTER. WORLD JOURNAL OF UROLOGY (2023) 41:1935-1941. HTTPS://DOI.ORG/10.1007/S00345-023-04438-4.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE WORLD JOURNAL OF UROLOGY THAT A RETROSPECTIVE STUDY WAS CONDUCTED. THE AIM OF THE STUDY WAS TO ANALYZE THE SAFETY AND EFFICACY OF THE POP-DUSTING TECHNIQUE FOR LARGE STONE TREATMENT PERFORMED DURING URETEROSCOPY WITH LASER LITHOTRIPSY WITH HOLMIUM LASER. DATA FROM 201 PATIENTS WHO WERE TREATED WITH URSL FROM JANUARY 2016 TO MAY 2022 PRESENTED WITH STONES LARGER THAN 15 MM AND TREATED USING BOSTON SCIENTIFIC HIGH-POWER HO: YAG LASER (EITHER 60W MOSES LASER OR 100 W). THE PROCEDURES WERE DONE UNDER A GENERAL ANESTHESIA. THE PATIENT LIED IN A LITHOTOMY POSITION IN ALL CASES. THE LASER MACHINES USED WERE A LUMENIS PULSE 100H AND VERSAPULSE POWERSUITE 60-WATT HOLMIUM LASER WITH MOSES TECHNOLOGY. THE POP DUSTING TECHNIQUE AND FEW FRAGMENT WERE RETRIEVE USING A BOSTON SCIENTIFIC CORPORATION NITINOL BASKET. THE MALE: FEMALE RATIO OF PATIENTS WHO UNDERWENT THE URSL PROCEDURE WAS 130:71. OUT OF A TOTAL OF 201 PATIENTS (222 PROCEDURES) WHO UNDERWENT URSL PROCEDURE COMPLICATIONS OCCURRED IN A TOTAL OF 7 (3.4%) PATIENTS, OF WHICH 6 PATIENTS PRESENTED WITH UROSEPSIS REQUIRING IV ANTIBIOTICS AND HOSPITAL ADMISSION (2.9%) (CLAVIEN DINDO II). ONE PATIENT (0.4%) PRESENTED WITH UROSEPSIS REQUIRING BRIEF INTENSIVE CARE SUPPORT (CLAVIEN DINDO IVA). THIS REPORT IS 1 OF 3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128574 PULSE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-P100

    Patients

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