BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM PLUS

    MDR report key: 12069765 · Received June 25, 2021

    Report

    Report Number
    3008062894-2021-00001
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    May 7, 2021
    Report Date
    July 13, 2021
    Manufacturer
    CAPSOVISION, INC.
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT WAS MADE ON (B)(6) 2021. THIS FOLLOW-UP REPORT IS MADE ON 2021-07-13 AFTER DEVICE WAS RETURNED FOR EVALUATION. SEE ATTACHED COMPLETED REPORT (B)(4).

    Description of Event or Problem · 0

    (B)(6) 2020 DR. (B)(6) ((B)(6) GASTROENTEROLOGY & LIVER INSTITUTE) PRESCRIBED CAPSULE TO PATIENT. PATIENT INGESTED CAPSULE. (B)(6) 2020 KUBXRS: CAPSULE WAS OVERLYING HEPATIC FLEXURE. (B)(6) 2020 KUBXRS: CAPSULE HAD MOVED INTO SIGMOID COLON. (B)(6) 2021 SURGERY PERFORMED: EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION. DR. (B)(6) PALPATED SMALL BOWEL, FOUND CAPSULE AND REMOVED SEGMENT OF BOWEL THAT CONTAINED CAPSULE, BOWEL WAS REANASTOMOSED AND PLACED INTO ABDOMINAL CAVITY. PATIENT WAS HOSPITALIZED. (B)(6) 2021 PATIENT IS DOING WELL AND WAS DISCHARGED.

    Description of Event or Problem · 1

    ON (B)(6) 2020 DR. (B)(6) PRESCRIBED CAPSULE TO PATIENT. PATIENT INGESTED CAPSULE. ON (B)(6) 2020 CAPSULE WAS OVERLYING HEPATIC FLEXURE. ON (B)(6) 2020 CAPSULE HAD MOVED INTO SIGMOID COLON. ON (B)(6) 2021 SURGERY PERFORMED: EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION. DR. (B)(6) PALPATED SMALL BOWEL, FOUND CAPSULE AND REMOVED SEGMENT OF BOWEL THAT CONTAINED CAPSULE, BOWEL WAS REANASTOMOSED AND PLACED INTO ABDOMINAL CAVITY. PATIENT WAS HOSPITALIZED. ON (B)(6) 2021 PATIENT IS DOING WELL AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961611 CAPSOCAM PLUS SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC. SV-3 01-19-0123

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R