BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERSUITE

    MDR report key: 25032859 · Received April 29, 2026

    Report

    Report Number
    2124215-2026-23158
    Event Type
    Injury
    Date Received
    April 29, 2026
    Date of Event
    August 11, 2023
    Report Date
    April 29, 2026
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    PMA / PMN Number
    K170121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RADHIKA CHAVAN, VATSAL BACHKANIWALA, CHAITI GANDHI, VIVEK JOSHI, AND SANJAY RAJPUT. (2023). EFFICACY AND SAFETY OF DIGITAL SINGLE-OPERATOR CHOLANGIOSCOPY-GUIDED LASER LITHOTRIPSY FOR REMNANT CYSTIC DUCT STONE - A SINGLE TERTIARY CARE CENTER EXPERIENCE. INDIAN JOURNAL OF GASTROENTEROLOGY (JULY - AUGUST 2024) 43(4):841-844. HTTPS://DOI.ORG/10.1007/S12664-023-01418-9.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THROUGH A LITERATURE ARTICLE PUBLISHED IN THE INDIAN JOURNAL OF GASTROENTEROLOGY, THAT A CLINICAL STUDY WAS DONE TO EVALUATE FEASIBILITY AND EFFECTIVITY OF CHOLANGIOSCOPY-GUIDED LASER LITHOTRIPSY IN TREATING REMNANT CYSTIC DUCT STONES (CDS). 167 PATIENTS UNDERWENT SINGLE OPERATOR CHOLANGIOSCOPPY (DSOC) FROM (B)(6) 2022. SUBSEQUENTLY, 22 OF THOSE PATIENTS THEN UNDERWENT LASER LITHOTRIPSY FOR CDS. THE LASER LITHOTRIPSY WAS PERFORMED UNDER DIRECT VISUALIZATION USING THE LUMENIS VERSAPULSE P20 CONSOLE. THE PROCEDURE INVOLVED DIRECT VISUALIZATION OF THE BILE DUCT AND CYSTIC DUCT USING A CHOLANGIOSCOPE, FOLLOWED BY LASER ENERGY DELIVERY TO FRAGMENT THE STONES SO THEY COULD BE REMOVED SAFELY. FOLLOWING THE PROCEDURE, ADVERSE PATIENT EFFECTS WERE REPORTED IN THREE PATIENTS. THESE INCLUDED ONE CASE OF MILD CHOLANGITIS, ONE CASE OF MILD ACUTE PANCREATITIS, AND ONE CASE OF MODERATELY SEVERE ACUTE PANCREATITIS. THERE WERE NO SERIOUS ADVERSE EVENTS OBSERVED. OVERALL, THE STUDY CONCLUDED THAT CHOLANGIOSCOPY GUIDED LASER LITHOTRIPSY IS A SAFE AND EFFECTIVE MINIMALLY INVASIVE ALTERNATIVE TO SURGERY FOR SELECTED PATIENTS WITH REMNANT CYSTIC DUCT STONES, WITH A LOW RATE OF MANAGEABLE ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34120 POWERSUITE POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD UNK-P-P20

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Other