BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSOCAM SV-3

    MDR report key: 23238596 · Received October 7, 2025

    Report

    Report Number
    3008062894-2025-00026
    Event Type
    Death
    Date Received
    October 7, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 6, 2025
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K242643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    8/15/2025 - THE DOWNLOAD CENTER RECEIVED A PACKAGE ON 8/14/2025 WITH THE CONTAINER BUT NO CAPSULE INSIDE. CUSTOMER WAS NOTIFIED AND TOLD THAT THEY MAY WANT TO REACH TO THE PATIENT TO SEE IF THEY STILL HAVE THE CAPSULE WITH THEM. IF NOT, A KUB X-RAY MAY BE NECESSARY TO CONFIRM CAPSULE EXCRETION. 8/28/2025 - WE WERE NOTIFIED THAT THE CUSTOMER CALLED BOTH THE PATIENT AND THE PATIENT'S DAUGHTER, LEFT A MESSAGE BUT DID NOT RECEIVE ANY CALLBACK. 9/15/2025 - WE REQUESTED AN UPDATE ON THE PATIENT AND WERE NOTIFIED THAT THE PATIENT NOR THE PATIENT'S DAUGHTER HAVE BEEN ANSWERING CALLS. 9/25/2025 - WE REACHED OUT AGAIN TO THE CUSTOMER REQUESTING UPDATES FROM THIS PATIENT AND WERE NOTIFIED THAT THE PATIENT HAD PASSED AWAY. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. 9/29/2025 - COMPLETED FORM AND ADDITIONAL DOCUMENTS SUCH AS A NURSE VISIT REPORT WERE RECEIVED INDICATING THE PATIENT HAD MULTIPLE PRE-EXISTING CONDITIONS SUCH AS ARTHRITIS, CAROTID ARTERY STENOSIS, COLITIS, COPD, CORONARY ARTERY DISEASE, DIVERTICULOSIS, ESOPHAGITIS, FRACTURE OF A RIB, HIATAL HERNIA, HIGH BLOOD PRESSURE, ISCHEMIC COLITIS, MYOCARDIAL INFARCTION, SACRAL INSUFFICIENCY FRACTURE AND SPINAL FRACTURE OF T10 VERTEBRA. THE FRM-0089C INDICATED THAT THE PATIENT INGESTED THE CAPSULE ON (B)(6) 2025 AND AFTERWARDS THE MEDICAL ASSISTANT CALLED THE PATIENT'S DAUGHTER SEVERAL TIMES AND LEFT VOICEMAILS REQUESTING A CALL TO DISCUSS CAPSULE CONTAINER THAT HAD BEEN RETURNED EMPTY, BUT THERE WAS NO RESPONSE. THE CUSTOMER THEN LOOKED INTO THEIR SYSTEM AND DISCOVERED THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2025. BASED ON THE INFORMATION PROVIDED WE CANNOT CONFIRM IF THE CAPSULE WAS RETAINED OR IN ANY WAY RELATED TO THE DEFUNCTION. WE WILL CONTINUE TO REQUEST ADDITIONAL INFORMATION FROM THE CUSTOMER AND IF THERE IS ANY NEW INFORMATION WE WILL PROVIDE AN UPDATE.

    Description of Event or Problem · 0

    ON 8/15/2025 - THE DOWNLOAD CENTER RECEIVED A PACKAGE ON 8/14/2025 WITH THE CONTAINER BUT NO CAPSULE INSIDE. CUSTOMER WAS NOTIFIED AND TOLD THAT THEY MAY WANT TO REACH TO THE PATIENT TO SEE IF THEY STILL HAVE THE CAPSULE WITH THEM. IF NOT, A KUB X-RAY MAY BE NECESSARY TO CONFIRM CAPSULE EXCRETION. ON (B)(6) 2025 - WE WERE NOTIFIED THAT THE CUSTOMER CALLED BOTH THE PATIENT AND THE PATIENT'S DAUGHTER, LEFT A MESSAGE BUT DID NOT RECEIVE ANY CALLBACK. ON 9/15/2025 - WE REQUESTED AN UPDATE ON THE PATIENT AND WERE NOTIFIED THAT THE PATIENT NOR THE PATIENT'S DAUGHTER HAVE BEEN ANSWERING CALLS. ON 9/25/2025 - WE REACHED OUT AGAIN TO THE CUSTOMER REQUESTING UPDATES FROM THIS PATIENT AND WERE NOTIFIED THAT THE PATIENT HAD PASSED AWAY. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. ON 9/29/2025 - COMPLETED FORM AND ADDITIONAL DOCUMENTS SUCH AS A NURSE VISIT REPORT WERE RECEIVED INDICATING THE PATIENT HAD MULTIPLE PRE-EXISTING CONDITIONS SUCH AS ARTHRITIS, CAROTID ARTERY STENOSIS, COLITIS, COPD, CORONARY ARTERY DISEASE, DIVERTICULOSIS, ESOPHAGITIS, FRACTURE OF A RIB, HIATAL HERNIA, HIGH BLOOD PRESSURE, ISCHEMIC COLITIS, MYOCARDIAL INFARCTION, SACRAL INSUFFICIENCY FRACTURE AND SPINAL FRACTURE OF T10 VERTEBRA. THE FRM-0089C INDICATED THAT THE PATIENT INGESTED THE CAPSULE ON (B)(6) 2025 AND AFTERWARDS THE MEDICAL ASSISTANT CALLED THE PATIENT'S DAUGHTER SEVERAL TIMES AND LEFT VOICEMAILS REQUESTING A CALL TO DISCUSS CAPSULE CONTAINER THAT HAD BEEN RETURNED EMPTY, BUT THERE WAS NO RESPONSE. THE CUSTOMER THEN LOOKED INTO THEIR SYSTEM AND DISCOVERED THAT THE PATIENT HAD PASSED AWAY ON (B)(6) 2025. BASED ON THE INFORMATION PROVIDED WE CANNOT CONFIRM IF THE CAPSULE WAS RETAINED OR IN ANY WAY RELATED TO THE DEFUNCTION. WE WILL CONTINUE TO REQUEST ADDITIONAL INFORMATION FROM THE CUSTOMER AND IF THERE IS ANY NEW INFORMATION WE WILL PROVIDE AN UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653519 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-25-0095

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death