BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 23646732 · Received November 25, 2025

    Report

    Report Number
    3008062894-2025-00029
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 25, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) 2025 - WE WERE NOTIFIED OF A PATIENT WITH A RETAINED CAPSULE. (B)(4) CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO OBTAIN ADDITIONAL INFORMATION. (B)(6) 2025 - WE REQUESTED UPDATES FROM THE CUSTOMER AND WERE INFORMED THAT THE CUSTOMER CALLED THE PATIENT TO SEE IF THE CAPSULE WAS EXCRETED AND FOUND OUT THAT THE PATIENT IS WAITING FOR THE CAPSULE TO BE EXCRETED. (B)(6) 2025 - WE WERE NOTIFIED THAT THE PHYSICIAN REQUESTED ADDITIONAL IMAGING AND POSSIBLY ANOTHER ROUND OF PREP TO AID THE PATIENT TO EXCRETE THE CAPSULE. SINCE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, THE CAUSE OF THE RETENTION COULD NOT BE ASSESSED. FURTHERMORE, CAPSULE RETENTION IS DISCUSSED IN THE IFU UNDER "PATIENT CONDITION" AND "RISKS". A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS RECEIVED SUPPLEMENTAL INFORMATION: (B)(6) 2025 - COMPLETED (B)(4) WAS RECEIVED INDICATING THAT THE PATIENT HAD CHRONIC CONSTIPATION AND ANEMIA THAT COULD HAVE LED TO THE RETENTION. DOCTOR ORDERED A CT OF ABDOMEN AND PELVIS AND DEPENDING ON THE STATUS OF THE SCAN THEY WILL REFER TO SURGERY. (B)(6) 2025 - WE WERE NOTIFIED THAT THE CAPSULE WAS EXCRETED NATURALLY BUT NOT RETRIEVED. KUB WAS PERFORMED TO CONFIRM THE EXCRETION, THEREFORE NO FURTHER ACTION IS REQUIRED, AND THIS ISSUE WILL BE DEEMED AS CLOSED.

    Additional Manufacturer Narrative · 0

    (B)(6) 2025 - WE WERE NOTIFIED OF A PATIENT WITH A RETAINED CAPSULE. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO OBTAIN ADDITIONAL INFORMATION. (B)(6) 2025 - WE REQUESTED UPDATES FROM THE CUSTOMER AND WERE INFORMED THAT THE CUSTOMER CALLED THE PATIENT TO SEE IF THE CAPSULE WAS EXCRETED AND FOUND OUT THAT THE PATIENT IS WAITING FOR THE CAPSULE TO BE EXCRETED. (B)(6) 2025 - WE WERE NOTIFIED THAT THE PHYSICIAN REQUESTED ADDITIONAL IMAGING AND POSSIBLY ANOTHER ROUND OF PREP TO AID THE PATIENT TO EXCRETE THE CAPSULE. SINCE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, THE CAUSE OF THE RETENTION COULD NOT BE ASSESSED. FURTHERMORE, CAPSULE RETENTION IS DISCUSSED IN THE IFU UNDER "PATIENT CONDITION" AND "RISKS". A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS RECEIVED

    Description of Event or Problem · 0

    (B)(6) 2025 - WE WERE NOTIFIED OF A PATIENT WITH A RETAINED CAPSULE. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO OBTAIN ADDITIONAL INFORMATION. (B)(6) 2025 - WE REQUESTED UPDATES FROM THE CUSTOMER AND WERE INFORMED THAT THE CUSTOMER CALLED THE PATIENT TO SEE IF THE CAPSULE WAS EXCRETED AND FOUND OUT THAT THE PATIENT IS WAITING FOR THE CAPSULE TO BE EXCRETED. (B)(6) 2025 - WE WERE NOTIFIED THAT THE PHYSICIAN REQUESTED ADDITIONAL IMAGING AND POSSIBLY ANOTHER ROUND OF PREP TO AID THE PATIENT TO EXCRETE THE CAPSULE. SINCE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, THE CAUSE OF THE RETENTION COULD NOT BE ASSESSED. FURTHERMORE, CAPSULE RETENTION IS DISCUSSED IN THE IFU UNDER "PATIENT CONDITION" AND "RISKS". A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS RECEIVED SUPPLEMENTAL INFORMATION: (B)(6) 2025 - COMPLETED (B)(4) WAS RECEIVED INDICATING THAT THE PATIENT HAD CHRONIC CONSTIPATION AND ANEMIA THAT COULD HAVE LED TO THE RETENTION. DOCTOR ORDERED A CT OF ABDOMEN AND PELVIS AND DEPENDING ON THE STATUS OF THE SCAN THEY WILL REFER TO SURGERY. (B)(6) 2025 - WE WERE NOTIFIED THAT THE CAPSULE WAS EXCRETED NATURALLY BUT NOT RETRIEVED. KUB WAS PERFORMED TO CONFIRM THE EXCRETION, THEREFORE NO FURTHER ACTION IS REQUIRED, AND THIS ISSUE WILL BE DEEMED AS CLOSED.

    Description of Event or Problem · 0

    (B)(6) 2025 - WE WERE NOTIFIED OF A PATIENT WITH A RETAINED CAPSULE. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO OBTAIN ADDITIONAL INFORMATION. (B)(6) 2025 - WE REQUESTED UPDATES FROM THE CUSTOMER AND WERE INFORMED THAT THE CUSTOMER CALLED THE PATIENT TO SEE IF THE CAPSULE WAS EXCRETED AND FOUND OUT THAT THE PATIENT IS WAITING FOR THE CAPSULE TO BE EXCRETED. (B)(6) 2025 - WE WERE NOTIFIED THAT THE PHYSICIAN REQUESTED ADDITIONAL IMAGING AND POSSIBLY ANOTHER ROUND OF PREP TO AID THE PATIENT TO EXCRETE THE CAPSULE. SINCE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, THE CAUSE OF THE RETENTION COULD NOT BE ASSESSED. FURTHERMORE, CAPSULE RETENTION IS DISCUSSED IN THE IFU UNDER "PATIENT CONDITION" AND "RISKS". A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538750 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-25-0078

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other