BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITHO 150

    MDR report key: 24574555 · Received March 11, 2026

    Report

    Report Number
    3004378299-2026-00001
    Event Type
    Injury
    Date Received
    March 11, 2026
    Report Date
    March 11, 2026
    Manufacturer
    QUANTA SYSTEM S.P.A.
    Product Code
    GEX
    UDI-DI
    08059173391738
    PMA / PMN Number
    K141101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING A DETAILED CLINICAL INVESTIGATION INTO THE TWO REPORTED PROCEDURES, IT HAS BEEN ESTABLISHED THAT SPECIFIC PATIENT-RELATED FACTORS SIGNIFICANTLY INFLUENCED THE CLINICAL OUTCOMES. NOTABLY, ONE OF THE PATIENTS PRESENTED WITH SEVERE PROSTATIC HYPERPLASIA, FEATURING AN ESTIMATED VOLUME OF 250 CC. SUCH EXTREME ANATOMICAL DIMENSIONS REPRESENT A CRITICAL CONFOUNDING FACTOR THAT INCREASED SURGICAL COMPLEXITY AND INHERENTLY ELEVATED THE DOCUMENTED RISK OF POST-OPERATIVE BLEEDING, WHICH IS A KNOWN SIDE EFFECT OF THESE INTERVENTIONS. DESPITE THESE CHALLENGES, NO SERIOUS CLINICAL CONSEQUENCES OCCURRED IN EITHER CASE, AND PHYSIOLOGICAL PARAMETERS WERE SUCCESSFULLY RESTORED WITHOUT THE NEED FOR BLOOD TRANSFUSIONS. THE COMPANY IS ACTIVELY MONITORING SIMILAR EVENTS THROUGH ITS POST-MARKET SURVEILLANCE (PMS) AND IS COLLECTING FURTHER CLINICAL DATA REGARDING THE USE OF LITHO 150 DEVICE IN MAGNETO MODE, INCLUDING HIGH-VOLUME PROCEDURES, TO REFINE ITS SAFETY PROFILE. BASED ON CURRENT EVIDENCE, THESE EPISODES DO NOT REPRESENT A SIGNIFICANT DEVIATION FROM ESTABLISHED SAFETY ANALYSES, AND THE BENEFIT-RISK RATIO REMAINS FAVORABLE. WE ARE CURRENTLY AWAITING FURTHER TECHNICAL INVESTIGATION RESULTS FROM THE DISTRIBUTOR REGARDING FIBER LOT A253165 TO COMPLETE THE FINAL CAUSALITY ASSESSMENT.

    Description of Event or Problem · 0

    THIS REPORT CONCERNS TWO CASES OF DELAYED POSTOPERATIVE HEMORRHAGE FOLLOWING HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURES, NOTIFIED BY DISTRIBUTOR ON 03/05/2026. BOTH PATIENTS REQUIRED EMERGENCY READMISSION ON THE FIRST POSTOPERATIVE NIGHT DUE TO GROSS HEMATURIA AND OBSTRUCTIVE CLOT FORMATION. IN BOTH INSTANCES, SURGICAL INTERVENTION USING A BIPOLAR ROLLER BALL WAS NECESSARY TO MANAGE THE BLEEDING AND EVACUATE THE CLOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579031 LITHO 150 SURGICAL LASER GEX QUANTA SYSTEM S.P.A. PVMS00062 08059173391738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization