BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19722205 · Received July 11, 2024

    Report

    Report Number
    3008062894-2024-00038
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    April 12, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    4/12/2023 - WE WERE CONTACTED BY A PATIENT'S HUSBAND WHO STATED THAT HIS WIFE HAS A CAPSOCAM STUCK IN HER SMALL INTESTINE FOR SEVERAL MONTHS. AND HE WAS READING ONLINE ABOUT DIFFERENT METHODS OF RETRIEVAL BUT WANTED TO KNOW WHAT METHOD IS MOST OFTEN USED FOR RETRIEVAL TODAY. 4/13/2023 - WE REACHED OUT TO THE PATIENT'S HUSBAND INDICATING THAT THEY SHOULD DISCUSS IT WITH HIS WIFE GASTROENTEROLOGIST. WE ALSO ADVISED THAT THE METHOD FOR CAPSULE RETRIEVAL WILL DEPEND ON SEVERAL FACTORS, INCLUDING THE INDICATION FOR THE CAPSULE ENDOSCOPY EXAMINATION AND THE SUSPECTED REASON FOR THE RETENTION. WE REQUESTED THE INFORMATION OF THE GASTROENTEROLOGIST FROM THE PATIENTS' HUSBAND SO WE CAN SEND THE FRM-89 TO BE COMPLETED. PATIENTS HUSBAND WAS CONTACTED SEVERAL TIMES ON 4/17/2023, 4/24/2023, 5/1/2023 & 5/19/2023 WITHOUT ANY RESPONSE, THEREFORE THIS COMPLAINT WAS CLOSED AND WILL BE RE-OPENED IF FURTHER INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    4/12/2023 - WE WERE CONTACTED BY A PATIENT'S HUSBAND WHO STATED THAT HIS WIFE HAS A CAPSOCAM STUCK IN HER SMALL INTESTINE FOR SEVERAL MONTHS. AND HE WAS READING ONLINE ABOUT DIFFERENT METHODS OF RETRIEVAL BUT WANTED TO KNOW WHAT METHOD IS MOST OFTEN USED FOR RETRIEVAL TODAY. 4/13/2023 - WE REACHED OUT TO THE PATIENT'S HUSBAND INDICATING THAT THEY SHOULD DISCUSS IT WITH HIS WIFE GASTROENTEROLOGIST. WE ALSO ADVISED THAT THE METHOD FOR CAPSULE RETRIEVAL WILL DEPEND ON SEVERAL FACTORS, INCLUDING THE INDICATION FOR THE CAPSULE ENDOSCOPY EXAMINATION AND THE SUSPECTED REASON FOR THE RETENTION. WE REQUESTED THE INFORMATION OF THE GASTROENTEROLOGIST FROM THE PATIENTS' HUSBAND SO WE CAN SEND THE FRM-89 TO BE COMPLETED. PATIENTS HUSBAND WAS CONTACTED SEVERAL TIMES ON 4/17/2023, 4/24/2023, 5/1/2023 & 5/19/2023 WITHOUT ANY RESPONSE, THEREFORE THIS COMPLAINT WAS CLOSED AND WILL BE RE-OPENED IF FURTHER INFORMATION IS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386093 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other