BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSOCAM SV-3

    MDR report key: 22061772 · Received May 21, 2025

    Report

    Report Number
    3008062894-2025-00011
    Event Type
    Death
    Date Received
    May 21, 2025
    Date of Event
    April 28, 2025
    Report Date
    May 20, 2025
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K242643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025 - WE WERE NOTIFIED OF A PATIENT WHO PASSED AWAY. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO GATHER ADDITIONAL INFORMATION. FRM-0089C WAS RECEIVED INDICATING PATIENT HAD PRE-EXISTING CONDITIONS AND THAT THE PATIENT CAME IN A "WHEELCHAIR DUE TO BILATERAL AMPUTEE" AND THAT A "NURSE FROM THE PATIENT'S LONG-TERM FACILITY WHO VERIFIED BOWEL PREP. PATIENT THEN SWALLOWED THE VIDEO CAPSULE EASILY WITH A SMALL AMOUNT OF WATER. PATIENT THEN LEFT VIA MEDICAL TRANSPORT IN SAME CONDITION AS ARRIVAL". THE DATE OF DEATH WAS NOTED AS (B)(6) 2025. AFTER REQUESTING THE REASON FOR THE CAUSE OF THE DEATH WE WERE INFORMED THAT THE CAUSE WAS UNKNOWN. THE PATIENT HAD MULTIPLE COMORBIDITIES, SHE LIVED A LONG-TERM CARE FACILITY AND THEY DID NOT KNOW THE EXACT CAUSE OF DEATH." ON (B)(6) 2025 - WE WERE INFORMED THAT THE CAPSULE PROCEDURE WAS ADMINISTERED DUE TO THE PATIENT BEING ANEMIC. TO DATE, WE ARE STILL WAITING FOR ADDITIONAL INFORMATION TO IDENTIFY THE CAUSE OF THE DEATH.

    Description of Event or Problem · 0

    ON (B)(6) 2025 - WE WERE NOTIFIED OF A PATIENT WHO PASSED AWAY. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO GATHER ADDITIONAL INFORMATION. FRM-0089C WAS RECEIVED INDICATING PATIENT HAD PRE-EXISTING CONDITIONS AND THAT THE PATIENT CAME IN A "WHEELCHAIR DUE TO BILATERAL AMPUTEE" AND THAT A "NURSE FROM THE PATIENT'S LONG-TERM FACILITY WHO VERIFIED BOWEL PREP. PATIENT THEN SWALLOWED THE VIDEO CAPSULE EASILY WITH A SMALL AMOUNT OF WATER. PATIENT THEN LEFT VIA MEDICAL TRANSPORT IN SAME CONDITION AS ARRIVAL". THE DATE OF DEATH WAS NOTED AS (B)(6) 2025. AFTER REQUESTING THE REASON FOR THE CAUSE OF THE DEATH WE WERE INFORMED THAT THE CAUSE WAS UNKNOWN. THE PATIENT HAD MULTIPLE COMORBIDITIES, SHE LIVED A LONG-TERM CARE FACILITY AND THEY DID NOT KNOW THE EXACT CAUSE OF DEATH." ON (B)(6) 2025 - WE WERE INFORMED THAT THE CAPSULE PROCEDURE WAS ADMINISTERED DUE TO THE PATIENT BEING ANEMIC. TO DATE, WE ARE STILL WAITING FOR ADDITIONAL INFORMATION TO IDENTIFY THE CAUSE OF THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72103 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-23-0037

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Death