BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 23831570 · Received December 17, 2025

    Report

    Report Number
    3027664504-2025-00040
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 15, 2025
    Report Date
    December 17, 2025
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962082
    PMA / PMN Number
    K241902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE CASE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A 71-YEAR-OLD MALE PATIENT WITH A HISTORY OF HEPATOCELLULAR CARCINOMA RECEIVED HISTOTRIPSY TREATMENT(S) TO TWO LESIONS IN LIVER SEGMENT V. THE PATIENT HAS A HISTORY OF CHRONIC HEPATITIS B (HBSAG POSITIVE) AND THYROID CARCINOMA STATUS POST RESECTION IN 2005. HE WAS DIAGNOSED WITH GRADE 2 HEPATOCELLULAR CARCINOMA AND UNDERWENT A PARTIAL RIGHT HEPATECTOMY IN 2007, WITH SUBSEQUENT RECURRENCE TREATED WITH FIVE SESSIONS OF TRANSARTERIAL CHEMOEMBOLIZATION BETWEEN 2008 AND 2023. HIS COURSE WAS COMPLICATED BY LIVER ABSCESSES REQUIRING DRAINAGE IN (B)(6) 2023, (B)(6) 2024. AN MRI PERFORMED IN CHINA ON (B)(6) 2025 SUGGESTED TWO HEPATIC LESIONS, WITH AN ALPA FETO-PROTEIN (AFP) LEVEL OF 3.0. THE PATIENT RECEIVED 1.2G OF AUGMENTIN VIA IV PROPHYLACTICALLY, ONE HOUR PRIOR TO HISTOTRIPSY. THE PATIENT WAS STABLE POST-PROCEDURE. THE FOLLOWING DAY, THE PATIENT DEVELOPED SEPSIS WITH A WHITE BLOOD CELL COUNT OF 18.7; BLOOD CULTURES GREW E. COLI AND KLEBSIELLA OXYTOCA. THIS SEPSIS WAS TREATED WITH IV ERTAPENEM (INVANZ) WITH SUBSEQUENT CONTROL AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245911 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R