BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR GI

    MDR report key: 24720437 · Received March 30, 2026

    Report

    Report Number
    3017448360-2026-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 27, 2026
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES CORP.
    Product Code
    FFX
    UDI-DI
    08717775955047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT DETAILS A MALFUNCTION OF THE SOLAR GI DEVICE, A MALFUNCTION THAT WAS NOT OBSERVED DURING USE OF THE DEVICE ON A PATIENT. ON DECEMBER 18, 2025, LABORIE HAD A MEETING WITH THE FDA WHERE IN FDA REQUESTED COMPLAINTS FOR NEGATIVE PRESSURE BE RE-EVALUATED AND SUBMITTED AS AN MDR.

    Description of Event or Problem · 0

    CUSTOMER RETURNED GI PUMP FOR REPAIR AS IT WAS REPORTED THE DEVICE WAS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407226 SOLAR GI SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX LABORIE MEDICAL TECHNOLOGIES CORP. SOLAR GI LGI H2O 115V 08717775955047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other