BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 23880114 · Received December 23, 2025

    Report

    Report Number
    3008062894-2025-00031
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 22, 2025
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K242643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2025 - WE WERE NOTIFIED OF A PATIENT WHO HAD A CAPSULE REMOVED VIA ENTEROSCOPY. BASED ON THE INFORMATION PROVIDED THE "CAPSULE WAS STUCK DUE TO ANATOMICAL CHANGES VIA PRIOR PROCEDURE". FRM-0089C - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE CASE WAS OPENED. DUE TO THE LACK OF INFORMATION RECEIVED, THE CAUSE OF THE REPORTED ISSUE COULD NOT BE ASSESSED. WE WILL CONTINUE TO FOLLOW UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION AND SUBMIT A FOLLOW-UP REPORT ONCE ANY INFORMATION IS RECEIVED

    Description of Event or Problem · 0

    (B)(6) 2025 - WE WERE NOTIFIED OF A PATIENT WHO HAD A CAPSULE REMOVED VIA ENTEROSCOPY. BASED ON THE INFORMATION PROVIDED THE "CAPSULE WAS STUCK DUE TO ANATOMICAL CHANGES VIA PRIOR PROCEDURE". FRM-0089C - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE CASE WAS OPENED. DUE TO THE LACK OF INFORMATION RECEIVED, THE CAUSE OF THE REPORTED ISSUE COULD NOT BE ASSESSED. WE WILL CONTINUE TO FOLLOW UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION AND SUBMIT A FOLLOW-UP REPORT ONCE ANY INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2532092 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-25-0223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention