BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDISON

    MDR report key: 24905557 · Received April 16, 2026

    Report

    Report Number
    3027664504-2026-00013
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 16, 2026
    Manufacturer
    HISTOSONICS, INC.
    Product Code
    QGM
    UDI-DI
    00850006962082
    PMA / PMN Number
    K241902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TREATING PHYSICIAN DOCUMENTED THAT THE PATIENT WAS COUNSELED REGARDING ELEVATED RISK OF GASTRIC INJURY DUE TO PROXIMITY OF ONE OF THE TARGETED LIVER TUMORS AND PROVIDED INFORMED CONSENT TO PROCEED GIVEN LIMITED OTHER TREATMENT OPTIONS. NO DEVICE MALFUNCTIONS OR OTHER NOTEWORTHY EVENTS OCCURRED DURING THE HISTOTRIPSY PROCEDURE. THE PROXIMITY OF THE HISTOTRIPSY TREATMENT VOLUME TO THE GASTRIC WALL IS CONSISTENT WITH A PROCEDURAL MECHANISM FOR THE OBSERVED GASTRIC INJURY.

    Description of Event or Problem · 0

    ON (B)(6), 2026, A 52-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF METASTATIC GRANULOSA CELL TUMOR INVOLVING THE LIVER RECEIVED HISTOTRIPSY TO MULTIPLE HEPATIC LESIONS IN SEGMENTS II, III, AND VI, FOR A TOTAL PLANNED TREATMENT VOLUME (PTV) OF 52.48 CC. ONE OF THE TUMORS TARGETED WAS ADJACENT TO THE STOMACH. THE PATIENT HAD AN EXTENSIVE ONCOLOGIC AND SURGICAL HISTORY, INCLUDING PRIOR TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY (TAH/BSO), MULTIPLE HEPATIC RESECTIONS, PERITONEAL DEBULKING PROCEDURES, AND MULTIPLE LINES OF SYSTEMIC THERAPY. RADIOLOGY REVIEW OF IMMEDIATE POST-TREATMENT IMAGING INDICATED "POST-TREATMENT CHANGES IN THE LIVER [WITH] INFLAMMATORY CHANGES EXTEND[ING] FROM SEGMENT II/III TO THE GASTRIC WALL AND OBLITERATION THE FAT PLANE [BETWEEN THE LIVER AND STOMACH]", WHICH WAS BELIEVED TO BE A SUPERFICIAL INJURY TO THE STOMACH. FOLLOWING DISCHARGE FROM THE POST-ANESTHESIA CARE UNIT, THE PATIENT DEVELOPED PERSISTENT BACK AND UPPER ABDOMINAL PAIN AND SHORTNESS OF BREATH, PROMPTING PRESENTATION TO AN OUTSIDE EMERGENCY DEPARTMENT ON POD0. IMAGING AT THAT TIME DEMONSTRATED A FOCAL DISRUPTION OF THE LATERAL WALL OF THE STOMACH WITH ADJACENT EXTRALUMINAL AIR AND FLUID, CONSISTENT WITH A CONTAINED GASTRIC PERFORATION. THE PATIENT WAS INITIATED ON INTRAVENOUS ANTIBIOTICS, ANTIFUNGAL THERAPY, AND PROTON PUMP INHIBITOR (PPI) THERAPY. GENERAL SURGERY WAS CONSULTED, AND GIVEN THE PATIENT'S EXTENSIVE PRIOR SURGICAL HISTORY, CONSERVATIVE, NON-OPERATIVE MANAGEMENT WAS RECOMMENDED. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO A TERTIARY CARE CENTER FOR CONTINUED MANAGEMENT. PER THE TREATING PHYSICIAN, THE PATIENT FAILED TO IMPROVE WITH EXPECTANT/ENDOSCOPIC MEASURES AND ULTIMATELY UNDERWENT A PARTIAL GASTRECTOMY ON (B)(6). THE PATHOLOGY SHOWED A 3 CM DEFECT IN THE STOMACH ADJACENT TO THE TARGETED LIVER TUMOR. PER THE TREATING PHYSICIAN, THE PTV MAY HAVE INCLUDED THE ADJACENT STOMACH. THE PATIENT HAD A VERY LONG/THIN LIVER WITH EXTENSIVE ADHESIONS THAT MADE TARGETING CHALLENGING. THE PATIENT RECOVERED WELL FROM SURGERY AND WAS DISCHARGED 5 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80653 EDISON Focused ultrasound system for non-thermal, mechanical tissue ablation QGM HISTOSONICS, INC. 00850006962082

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| H| O