BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION X1

    MDR report key: 13006612 · Received December 14, 2021

    Report

    Report Number
    3011716550-2021-00001
    Event Type
    Injury
    Date Received
    December 14, 2021
    Date of Event
    October 31, 2021
    Report Date
    November 15, 2021
    Manufacturer
    REFLEXION MEDICAL, INC.
    Product Code
    MUJ
    UDI-DI
    00860003983805
    PMA / PMN Number
    K190978
    Removal / Correction Number
    3011716550-12/9/21-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFLEXION HAS INVESTIGATED THE ISSUE AND DETERMINED THE CAUSE TO BE A CODE IMPLEMENTATION DEFECT IN THE TREATMENT PLANNING SOFTWARE. WHEN REFLEXION'S TREATMENT PLANNING SYSTEM CALCULATES DOSE, AN ACCURATE ORIENTATION FOR IMAGE, DOSE, PRIMARY BEAM, AND SCATTER ORIENTATION (DOSE ANGLES) IS NECESSARY. THE SCATTER ORIENTATION IN THE DOSE CALCULATION ALGORITHM IS INCORRECT FOR ANY PATIENT ORIENTATION OTHER THAN HEAD FIRST SUPINE (HFS). THE OTHER PATIENT ORIENTATIONS ARE HEAD FIRST PRONE (HFP), FEET FIRST PRONE (FFP), AND FEET FIRST SUPINE (FFS). TREATMENT PLANS FOR HFS ARE NOT AFFECTED.

    Description of Event or Problem · 0

    PATIENT (B)(6) RECEIVED 22 OUT OF 25 PLANNED FRACTIONS FOR PROSTATE BED + LYMPH NODE ON THE REFLEXION X1 SYSTEM, AND 3 ADDITIONAL FRACTIONS ON ANOTHER SYSTEM. DURING THE COURSE OF HIS TREATMENT, THE PATIENT RECEIVED AN OVERDOSE TO THE PTV OF 7.8%, EXCEEDING CLINICAL TREATMENT GOALS. THERE WERE ASSOCIATED OVERDOSES TO ORGANS AT RISK (OARS). THE ADDITIONAL DOSE TO THESE ORGANS MAY RAISE THE RISK OF SHORT-TERM OR LONG-TERM INJURY BEYOND KNOWN BASELINE RISKS OF PROSTATE BED RADIOTHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894810 REFLEXION X1 REFLEXION MEDICAL RADIOTHERAPY SYSTEM MUJ REFLEXION MEDICAL, INC. RXM1000 NA 00860003983805

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Other