BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSA ONE (JP)

    MDR report key: 23741576 · Received December 8, 2025

    Report

    Report Number
    3009185973-2025-00014
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 12, 2025
    Report Date
    May 28, 2026
    Manufacturer
    MEDTECH SAS
    Product Code
    HAW
    UDI-DI
    03760244034328
    PMA / PMN Number
    K231103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN - EVENT OCCURRED IN JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INTRACRANIAL ELECTRODE PLACEMENT FOR MONITORING, AND DIFFICULTY OCCURRED WITH REMOVAL OF ONE STEREOELECTROENCEPHALOGRAPHY (SEEG) ELECTRODE IN THE RIGHT FRONTAL REGION. AFTER MONITORING CONCLUDED, DURING THE REMOVAL PROCEDURE UNDER LOCAL ANESTHESIA IN THE OPERATING ROOM, DIFFICULTY AROSE IN EXTRACTING ONE SEEG ELECTRODE PLACED IN THE RIGHT FRONTAL REGION. THE ELECTRODE STUMP WAS TEMPORARILY BURIED SUBCUTANEOUSLY. SUBSEQUENTLY, DURING A LEFT FOCAL RESECTION, THE RIGHT FRONTAL ELECTRODE INSERTION SITE WAS INCISED, AND THE ELECTRODE WAS REMOVED USING A DRILL. THE PATIENT RECOVERED WELL WITHOUT POSTOPERATIVE COMPLICATIONS AND WAS DISCHARGED. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573831 ROSA ONE (JP) NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTECH SAS 3.1.6.490 03760244034328

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R