BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHOVUE ELITE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE

    MDR report key: 23852472 · Received December 19, 2025

    Report

    Report Number
    2124215-2025-92085
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 1, 2025
    Report Date
    February 10, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. APPROXIMATED BASED ON THE MONTH AND YEAR OF THE ARTICLE WAS PUBLISHED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK G2: NAEEM BHOJANI, MD, FRCSC; CONNOR M. FORBES, MD; BEN H. CHEW, MD; KATHRYN MORRIS, MPH; THEODORE TSACOGIANIS, MPH; JENIFER WHITE, BS, MHSA; SIRIKAN ROJANASAROT, PHD; ABIMBOLA WILLIAMS, MS, MPH; NATALIE EDWARDS, MSC; MANOJ MONGA, MD, FACS. BLOCK H6: IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E233001 CAPTURES THE REPORTABLE EVENT OF CHEST PAIN. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED INFECTION. IMDRF PATIENT CODE E0611 CAPTURES THE REPORTABLE EVENT OF HEART FAILURE. IMDRF PATIENT CODE E1310 CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY/ILLNESS. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. A DHR REVIEW WAS NOT PERFORMED AS THE LOT NUMBER IS UNKNOWN, AND SHIP HISTORY REVIEW DID NOT RETURN ANY PROBABLE LOTS. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. APPROXIMATED BASED ON THE MONTH AND YEAR OF THE ARTICLE WAS PUBLISHED. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME: UNIVERSITE DE MONTREAL - CENTRE HOSPITALIER DE L UNIVERSITE DE MONTREAL (CHUM). BLOCK G2: NAEEM BHOJANI, MD, FRCSC; CONNOR M. FORBES, MD; BEN H. CHEW, MD; KATHRYN MORRIS, MPH; THEODORE TSACOGIANIS, MPH; JENIFER WHITE, BS, MHSA; SIRIKAN ROJANASAROT, PHD; ABIMBOLA WILLIAMS, MS, MPH; NATALIE EDWARDS, MSC; MANOJ MONGA, MD, FACS. BLOCK H6: IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E233001 CAPTURES THE REPORTABLE EVENT OF CHEST PAIN. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF UNSPECIFIED INFECTION. IMDRF PATIENT CODE E0611 CAPTURES THE REPORTABLE EVENT OF HEART FAILURE. IMDRF PATIENT CODE E1310 CAPTURES THE REPORTABLE EVENT OF URINARY TRACT INFECTION. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY/ILLNESS IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LITHOVUE ELITE FLEXSCOPE WAS USED AND AMONG PATIENTS WHO RETURNED TO THE EMERGENCY DEPARTMENT OR REQUIRED INPATIENT ADMISSION WITHIN 30 DAYS AFTER URETEROSCOPY PROCEDURE (URS) WITH LVE PRESSURE SENSING TECHNOLOGY, THE MOST COMMON DOCUMENTED REASONS WERE COMPLICATIONS RELATED TO GENITOURINARY PROSTHETIC DEVICES (5 EVENTS), FOLLOWED BY SEPSIS, RECURRENT STONE DISEASE, THROAT OR CHEST PAIN, AND ABDOMINAL OR PELVIC PAIN (EACH WITH 2 EVENTS). SEVERAL ISOLATED DIAGNOSES INCLUDING FUNGAL INFECTIONS, METABOLIC OR ENDOCRINE ISSUES, HEART FAILURE, URINARY TRACT INFECTION, AND OTHER POSTPROCEDURAL OR HISTORICAL CONDITIONS AND EACH ACCOUNTED FOR A SINGLE EVENT. OVERALL, RETURNS WERE DRIVEN BY A MIX OF PROCEDURE RELATED COMPLICATIONS, INFECTIONS, PAIN RELATED PRESENTATIONS, AND UNRELATED COMORBID CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC AN EVENT INVOLVING A LITHOVUE ELITE FLEXSCOPE THROUGH A STUDY TO COMPARE POST-PROCEDURE HEALTHCARE RESOURCE UTILIZATION WITH LITHOVUE ELITE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE WITH PRESSURE MONITORING VS. OTHER (NON-PRESSURE SENSING) SINGLE-USE URETEROSCOPES. THE STUDY INCLUDED 305 PATIENTS WHO UNDERWENT URETEROSCOPY WITH LITHOTRIPSY BETWEEN JANUARY 1, 2024, AND MARCH 1, 2025. THE DOCUMENTED COMPLICATIONS INCLUDED COMPLICATIONS RELATED TO GENITOURINARY PROSTHETIC DEVICES (5 EVENTS), FOLLOWED BY SEPSIS, RECURRENT STONE DISEASE, THROAT OR CHEST PAIN, AND ABDOMINAL OR PELVIC PAIN (EACH WITH 2 EVENTS). SEVERAL ISOLATED DIAGNOSES INCLUDING FUNGAL INFECTIONS, METABOLIC OR ENDOCRINE ISSUES, HEART FAILURE, URINARY TRACT INFECTION, AND OTHER POSTPROCEDURAL OR HISTORICAL CONDITIONS AND EACH ACCOUNTED FOR A SINGLE EVENT. OVERALL, RETURNS WERE DRIVEN BY A MIX OF PROCEDURE RELATED COMPLICATIONS, INFECTIONS, PAIN RELATED PRESENTATIONS, AND UNRELATED COMORBID CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386521 LITHOVUE ELITE SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB BOSTON SCIENTIFIC CORPORATION UNK-P-LITHOVUE_ELITE_FLEXSCOPE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R