BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SYSTEM CAPSULES

    MDR report key: 23714184 · Received December 4, 2025

    Report

    Report Number
    3025305436-2025-00002
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 4, 2025
    Manufacturer
    VIBRANT LTD
    Product Code
    QTN
    PMA / PMN Number
    K232830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTION WAS IDENTIFIED. CAPSULE RETENTION OCCURRED IN A PATIENT WITH A KNOWN CONTRAINDICATION (HISTORY OF SMALL BOWEL OBSTRUCTION). IMAGING CONFIRMED FOUR RETAINED CAPSULES, AND THE PATIENT UNDERWENT SURGICAL RETRIEVAL AND RELATED PROCEDURES, INCLUDING INTERVENTION FOR UNDERLYING ANATOMICAL ISSUES. A REVIEW OF THE DHR FOR LOT C00425 CONFIRMED THAT THE PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN ACCORDANCE WITH VIBRANT SPECIFICATIONS. BECAUSE SURGICAL INTERVENTION WAS REQUIRED AND DEVICE CONTRIBUTION CANNOT BE RULED OUT BASED ON THE AVAILABLE INFORMATION, THE EVENT IS REPORTABLE UNDER 21 CFR 803.

    Description of Event or Problem · 0

    A 72-YEAR-OLD FEMALE USING THE VIBRANT CAPSULE SYSTEM FOR CHRONIC CONSTIPATION INGESTED FOUR CAPSULES BETWEEN (B)(6) 2025. SHE LATER REPORTED LACK OF CAPSULE EXPULSION AND NAUSEA. AN ABDOMINAL X-RAY SHOWED FOUR RETAINED CAPSULES. A CT SCAN ON (B)(6) 2025 SHOWED FOUR METALLIC CAPSULES IN THE RIGHT LOWER QUADRANT AT THE ILEUM WITH NO INTERVAL MOVEMENT. THE CT IMAGES WERE NOT PROVIDED TOO VIBRANT. THE PATIENT HAS A KNOWN HISTORY OF SMALL BOWEL OBSTRUCTION, A CONTRAINDICATION FOR VIBRANT USE. THERAPY WAS DISCONTINUED ONCE THIS WAS RECOGNIZED. THE PATIENT SUBSEQUENTLY UNDERWENT SURGERY. ACCORDING TO THE TREATING PHYSICIAN, THE PROCEDURE INCLUDED EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, RETRIEVAL OF THE FOUR VIBRANT CAPSULES, AND AN EXTENDED RIGHT HEMICOLECTOMY (PERFORMED FOR UNDERLYING ANATOMICAL ISSUES). NO OPERATIVE REPORT WAS PROVIDED. VIBRANT'S MEDICAL REVIEWER NOTED THE FINDINGS ARE COMPATIBLE WITH A POSSIBLE LOW-GRADE OBSTRUCTION; HOWEVER, BASED ON THE INFORMATION AVAILABLE, IT COULD NOT BE DETERMINED WHETHER THE OBSTRUCTION WAS PRE-EXISTING OR WHETHER THE CAPSULES CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979174 VIBRANT SYSTEM CAPSULES ORALLY INGESTED TRANSIENT DEVICE FOR CONSTIPATION QTN VIBRANT LTD C00425

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other