BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19722198 · Received July 11, 2024

    Report

    Report Number
    3008062894-2024-00034
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 9, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/20/2022 - WE WERE INFORMED OF A PATIENT WHO TOOK A CAPSOCAM AND A GIVEN PILLCAM AT THE SAME TIME, BOTH WERE REPORTED AS STUCK. FRM-0089 CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER FOR MORE INFORMATION REGARDING THE RETENTION. FROM INVESTIGATION, THE PATIENT HAD 2 PROCEDURES DONE, ONE WITH OUR CAPSULE A03GP6.726 AND ONE WITH PILLCAM. BASED ON THE INFORMATION FROM FRM-0089, THE PATIENT HAS A PRE-EXISTING CONDITION, NSAID ENTEROPATHY WITH MULTIPLE ULCERATED STRICTURES <1CM IN THE ILEUM DIAGNOSED BY THE PILLCAM, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE CAPSULE RETENTION. THE CAPSULE DID NOT PASS IN 3 DAYS, BUT THE CAPSOCAM WAS VISIBLE AT THE PELVIC RIM IN THE SMALL BOWEL ON (B)(6) 2022, ONE MONTH LATER A CT SCAN OF THE ABDOMEN AND PELVIC SHOWED THE CAPSOCAM AND PILLCAM WERE STUCK IN THE SMALL BOWEL ON (B)(6) 2022.

    Description of Event or Problem · 0

    ON 5/20/2022 - WE WERE INFORMED OF A PATIENT WHO TOOK A CAPSOCAM AND A GIVEN PILLCAM AT THE SAME TIME, BOTH WERE REPORTED AS STUCK. FRM-0089 CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER FOR MORE INFORMATION REGARDING THE RETENTION. FROM INVESTIGATION, THE PATIENT HAD 2 PROCEDURES DONE, ONE WITH OUR CAPSULE A03GP6.726 AND ONE WITH PILLCAM. BASED ON THE INFORMATION FROM FRM-0089, THE PATIENT HAS A PRE-EXISTING CONDITION, NSAID ENTEROPATHY WITH MULTIPLE ULCERATED STRICTURES <1CM IN THE ILEUM DIAGNOSED BY THE PILLCAM, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE CAPSULE RETENTION. THE CAPSULE DID NOT PASS IN 3 DAYS, BUT THE CAPSOCAM WAS VISIBLE AT THE PELVIC RIM IN THE SMALL BOWEL ON (B)(6) 2022, ONE MONTH LATER A CT SCAN OF THE ABDOMEN AND PELVIC SHOWED THE CAPSOCAM AND PILLCAM WERE STUCK IN THE SMALL BOWEL ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386087 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-21-0274

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other