BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19722249 · Received July 11, 2024

    Report

    Report Number
    3008062894-2024-00040
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 9, 2023
    Report Date
    July 10, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "6/9/2023 - WE WERE NOTIFIED OF A PATIENT WHO HAS NOT PASSED THE CAPSULE; THE PROCEDURE WAS CREATED ON MAY 31ST. FRM-89 WAS SENT TO THE CUSTOMER TO GATHER MORE INFORMATION. AFTER REACHING OUT TO THE CUSTOMER WITHOUT RESPONSE ON 6/13/2023 & 6/20/2023, WE FOUND OUT THAT THE PROCEDURE HAD BEEN COMPLETED AND THE VIDEO AND REPORT WERE ALREADY UPLOADED INTO CAPSOCLOUD, THEREFORE THE PATIENT WAS ABLE TO EXCRETE THE CAPSULE. FRM-89 WAS NEVER RECEIVED AND AS THE VIDEO AND REPORT WERE SUCCESSFULLY UPLOADED INTO CAPSOCLOUD THIS COMPLAINT WAS CLOSED AND WILL RE-OPEN IF FURTHER INFORMATION IS OBTAINED."

    Description of Event or Problem · 0

    6/9/2023 - WE WERE NOTIFIED OF A PATIENT WHO HAS NOT PASSED THE CAPSULE; THE PROCEDURE WAS CREATED ON MAY 31ST. FRM-89 WAS SENT TO THE CUSTOMER TO GATHER MORE INFORMATION. AFTER REACHING OUT TO THE CUSTOMER WITHOUT RESPONSE ON 6/13/2023 & 6/20/2023, WE FOUND OUT THAT THE PROCEDURE HAD BEEN COMPLETED AND THE VIDEO AND REPORT WERE ALREADY UPLOADED INTO CAPSOCLOUD, THEREFORE THE PATIENT WAS ABLE TO EXCRETE THE CAPSULE. FRM-89 WAS NEVER RECEIVED AND AS THE VIDEO AND REPORT WERE SUCCESSFULLY UPLOADED INTO CAPSOCLOUD THIS COMPLAINT WAS CLOSED AND WILL RE-OPEN IF FURTHER INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379816 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-22-0290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other