BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SYSTEM CAPSULES

    MDR report key: 25068068 · Received May 4, 2026

    Report

    Report Number
    3025305436-2026-00001
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 5, 2026
    Manufacturer
    VIBRANT LTD
    Product Code
    QTN
    PMA / PMN Number
    DEN210052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONFIRMED THAT THE PATIENT HAD BEEN USING VIBRANT SINCE (B)(6) 2025. THERE WERE 99 CAPSULE ACTIVATIONS RECORDED PRIOR TO THE COMPLAINT, INDICATING REPEATED USE OF THE DEVICE OVER SEVERAL MONTHS WITH NO PRIOR REPORTED ISSUES. REVIEW OF THE EVENT CHRONOLOGY CONFIRMED THAT THE LAST RECORDED CAPSULE ACTIVATION OCCURRED ON (B)(6) 2026 AND THAT FOUR CAPSULES WERE VISUALIZED DURING COLONOSCOPY ON (B)(6) 2026, APPROXIMATELY SIX DAYS LATER. THEREFORE, THE CAPSULES WERE NOT RETAINED FOR WEEKS AS DESCRIBED IN THE PATIENT-SUBMITTED FDA REPORT. THE COLONOSCOPY IMAGE AND EVENT DETAILS WERE REVIEWED BY A VIBRANT MEDICAL ADVISOR, A GASTROENTEROLOGIST, WHO CONCLUDED THAT NO MEDICAL INTERVENTION OR OTHER ACTION WAS REQUIRED AND THAT THE CAPSULES WOULD NOT CAUSE A BLOCKAGE. NO INJURY, ADVERSE HEALTH CONSEQUENCE, DEVICE MALFUNCTION, OR USE-RELATED DEVICE PROBLEM WAS IDENTIFIED. BASED ON THE DOCUMENTED CHRONOLOGY, MEDICAL ADVISOR ASSESSMENT, AND AVAILABLE CLINICAL EVIDENCE, VIBRANT ASSESSED THIS EVENT AS NON-REPORTABLE UNDER MDR CRITERIA.

    Description of Event or Problem · 0

    VIBRANT RECEIVED USER-SUBMITTED MEDWATCH REPORTS OF THE SAME EVENT (MW5185307, MW5185308, MW5185309, AND MW5185310) ON 14-APR-2026. ACCORDING TO VIBRANT RECORDS, THE PATIENT HAD BEEN USING VIBRANT SINCE (B)(6) 2025. THERE WERE 99 CAPSULE ACTIVATIONS RECORDED PRIOR TO THE COMPLAINT, INDICATING REPEATED USE OF THE DEVICE OVER SEVERAL MONTHS, WITH NO PRIOR REPORTED ISSUES. THE LAST RECORDED CAPSULE ACTIVATION WAS ON (B)(6) 2026. ON (B)(6) 2026, FOLLOWING BOWEL PREPARATION, THE PATIENT UNDERWENT COLONOSCOPY DURING WHICH FOUR CAPSULES WERE REPORTEDLY VISUALIZED IN TRANSIT IN THE COLON. THE EVENT DETAILS AND COLONOSCOPY IMAGE WERE FORWARDED TO A VIBRANT MEDICAL ADVISOR (GASTROENTEROLOGIST) FOR REVIEW. THE MEDICAL ADVISOR CONCLUDED THAT NO MEDICAL INTERVENTION OR OTHER ACTION WAS REQUIRED AND THAT THE CAPSULES WOULD NOT CAUSE A BLOCKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29017 VIBRANT SYSTEM CAPSULES ORALLY INGESTED TRANSIENT DEVICE FOR CONSTIPATION QTN VIBRANT LTD C01725

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Other