BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS SLIMLINE 200 D/F/L

    MDR report key: 17969539 · Received October 19, 2023

    Report

    Report Number
    2124215-2023-57714
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    May 1, 2022
    Report Date
    October 19, 2023
    Manufacturer
    LUMENIS LTD
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 IMPLANT 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. B3 DATE OF EVENT: APPROXIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF THE NEPAL MEDICAL ASSOCIATION THAT A DESCRIPTIVE CROSS-SECTIONAL STUDY WAS CONDUCTED FROM JUNE 2021 TO MAY 2022. THE AIM OF THIS STUDY WAS TO FIND OUT THE PREVALENCE OF COMPLETE STONE CLEARANCE AFTER RETROGRADE INTRA-RENAL SURGERY AMONG PATIENTS WITH UROLITHIASIS IN A TERTIARY CARE CENTER. 42 PATIENT WERE EVALUATED. ADULT PATIENTS WITH STONE SIZES UP TO 15 MM WHO WERE PLANNED FOR RIRS WERE INCLUDED IN THIS STUDY. PATIENTS WERE EVALUATED PREOPERATIVELY AS PER INSTITUTIONAL PROTOCOL. THE PROCEDURE WAS DONE EITHER IN GENERAL OR WITH SPINAL ANESTHESIA. SEMIRIGID URETEROSCOPY USING 6.5/7 FR URETEROSCOPE FROM KARL STORZ WAS DONE IN ALL PATIENTS BEFORE THE INTRODUCTION OF URETERAL ACCESS SHEATH. CALCULUS WAS DUSTED, FRAGMENTED OR POPCORNED USING A 20W LASER MACHINE (VERSA PULSE P20, LUMENIS) AND 200-MICRON LASER FIBER WITH ENERGY AND FREQUENCY RANGE OF 0.5-1.2 JOULES AND 6-14 HZ RESPECTIVELY. AMONG THE 42 PATIENTS, 36 (85.71%) PATIENTS (75.13-96.29, 95% CI) ACHIEVED COMPLETE STONE CLEARANCE AT 1 MONTH. MEAN AGE OF THE PATIENTS WAS 40.26+-14.05 WITH THE RANGE OF 16-74 YEARS WITH MALE PREDOMINANCE 21 (59.50%). STONES WERE EQUALLY DISTRIBUTED ON BOTH SIDES (50% EACH) AND MEAN STONE SIZE WAS 1.27+-0.19 (RANGE, 0.9-1.5) CM. THE LOCATION OF THE STONE WAS PELVI-URETERIC JUNCTION (PUJ)/ PELVIS 18 (50%), UPPER CALYX 8 (22.22%), PROXIMAL URETER 5 (13.89%), MID CALYX 3 (8.33%) AND LOWER CALYX 2 (5.56%) RESPECTIVELY. GRADE 3 URETERIC INJURY OCCURRED IN ONE PATIENT (2.38%) OF IMPACTED CALCULUS AT PUJ AND REQUIRED ANTEGRADE STENTING. UROSEPSIS OCCURRED IN 4 (9.52%) CASES WHICH REQUIRED EARLY STENT REMOVAL (WITHIN A WEEK POST PROCEDURE), AND RESIDUAL FRAGMENTS WERE SEEN IN 6 CASES (14,29%). IN CONCLUSION, THE PREVALENCE OF COMPLETE STONE CLEARANCE WAS SIMILAR AMONG PATIENTS UNDERGOING RETROGRADE INTRA-RENAL SURGERY IN OUR STUDY WHEN COMPARED TO OTHER STUDIES CONDUCTED IN SIMILAR SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94309 LUMENIS SLIMLINE 200 D/F/L POWERED LASER SURGICAL INSTRUMENT GEX LUMENIS LTD 1911-07

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R