BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19722204 · Received July 11, 2024

    Report

    Report Number
    3008062894-2024-00032
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    March 2, 2022
    Report Date
    July 10, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "THE CUSTOMER SENT HUMAN WASTE INSTEAD OF THE CAPSULE TO THE DOWNLOAD CENTER. DLC CONFIRMED THAT THERE'S NO CAPSULE. THE CUSTOMER WAS NOTIFIED OF THE INCIDENT AND WAS REQUESTED TO FOLLOW-UP WITH THE PATIENT TO INQUIRE ABOUT THE WHEREABOUTS OF THE CAPSULE. AN X-RAY IS ALSO RECOMMENDED TO THE CUSTOMER IF THE PHYSICIAN HAS ANY CONCERNS ABOUT RETENTION. A KUB X-RAY WAS PERFORMED ON (B)(6) 2022 AND SHOWED THE CAPSULE WAS INSIDE PATIENT'S SMALL BOWEL. PER FRM-0089 CAPSULE INCIDENT QUESTIONNAIRE THE CUSTOMER PROVIDED, SINCE THE PATIENT DOESN'T HAVE ANY PAIN NOR PASSING GAS AND HAVE REGULAR BM'S, NO SURGICAL OR FURTHER PROCEDURES WERE PLANNED AT THIS MOMENT. THEREFORE, THIS COMPLAINT WAS CLOSED AND FURTHER ACTIONS WILL BE TAKEN IF THERE IS ANY REPORTED CHANGE TO THIS ISSUE OR PATIENT STATUS."

    Description of Event or Problem · 0

    "THE CUSTOMER SENT HUMAN WASTE INSTEAD OF THE CAPSULE TO THE DOWNLOAD CENTER. DLC CONFIRMED THAT THERE'S NO CAPSULE. THE CUSTOMER WAS NOTIFIED OF THE INCIDENT AND WAS REQUESTED TO FOLLOW-UP WITH THE PATIENT TO INQUIRE ABOUT THE WHEREABOUTS OF THE CAPSULE. AN X-RAY IS ALSO RECOMMENDED TO THE CUSTOMER IF THE PHYSICIAN HAS ANY CONCERNS ABOUT RETENTION. A KUB X-RAY WAS PERFORMED ON (B)(6) 2022 AND SHOWED THE CAPSULE WAS INSIDE PATIENT'S SMALL BOWEL. PER FRM-0089 CAPSULE INCIDENT QUESTIONNAIRE THE CUSTOMER PROVIDED, SINCE THE PATIENT DOESN'T HAVE ANY PAIN NOR PASSING GAS AND HAVE REGULAR BM'S, NO SURGICAL OR FURTHER PROCEDURES WERE PLANNED AT THIS MOMENT. THEREFORE, THIS COMPLAINT WAS CLOSED AND FURTHER ACTIONS WILL BE TAKEN IF THERE IS ANY REPORTED CHANGE TO THIS ISSUE OR PATIENT STATUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386092 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-22-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other