BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSOCAM SV-3

    MDR report key: 19983317 · Received August 14, 2024

    Report

    Report Number
    3008062894-2024-00044
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 14, 2024
    Manufacturer
    CAPSOVISION, INC
    Product Code
    NEZ
    PMA / PMN Number
    K192662
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024 - WE WERE NOTIFIED OF A RETAINED CAPSULE THAT WAS SURGICALLY REMOVED AND COULD NOT BE DOWNLOADED AFTER THE EXTRACTION. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN FURTHER INFORMATION. AN RMA WAS ISSUED TO INVESTIGATE THE DEFECTIVE CAPSULE AND DOWNLOAD THE VIDEO. ON (B)(6) 2024 - FRM-0089C WAS RECEIVED INDICATING PATIENT HAD A PRE-EXISTING CONDITION (LAPAROSCOPIC LYSIS OF ADHESIONS IN (B)(6) 2023): THE CUSTOMER ALSO STATED THAT THE CAPSULE WAS SWALLOWED ON (B)(6) 2023 BY REMOTE INGESTION WITHOUT ANY ISSUES, BUT AFTER FOLLOW UPS 2 DAYS AFTER AND 8 DAYS AFTER THEY WERE INFORMED THAT THE CAPSULE HAD NOT BEEN EXCRETED. AFTER TELEHEALTH FOLLOW-UPS ON (B)(6) 23 WITH NO OBSTRUCTION SYMPTOMS, ON (B)(6) 2024 THE CUSTOMER WAS NOTIFIED THAT THE PATIENT HAD ONGOING PAIN ISSUES. THE PATIENT HAD A PARTIAL OBSTRUCTION CAUSED BY A STRICTURE IN THE ILEUM AS SHOWN IN IMAGING (CT-SCAN). ON (B)(6) 2024 THE PATIENT WENT TO ER WITH AND HAD A DIAGNOSIS OF A PEPTIC ULCER, PATIENT WENT AGAIN ON (B)(6) 2024 AND WAS GIVEN A DIAGNOSIS OF NAUSEA AND VOMITING, ON (B)(6) 2024 THE PATIENT HAD AN EGD INDICATING MODEST PATCHY ANTRAL GASTRITIS AND MODERATE PATCHY DUODENITIS. ON (B)(6) 2024 THE PATIENT WENT TO ER AGAIN WITH ACUTE ABDOMINAL PAIN AND WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2021 WITH A SUSPECTED PARTIAL/LOW-GRADE BOWEL OBSTRUCTION. ON (B)(6) 2024 THE PATIENT WAS PRESCRIBED GASTROGRAFIN AND WAS ADVISED OF SURGERY IF THEY DIDN'T PASS THE CAPSULE. ON (B)(6) 2024 - PATIENT HAD A SURGICAL PROCEDURE WITH CAPSULE REMOVAL. ON (B)(6) 2024 - THE CAPSULE ARRIVED AT CAPSOVISION AND THE INVESTIGATION DETERMINED THAT THERE WAS NO TECHNICAL FAILURES UPON REVIEWING THE VIDEO. THE CAPSULE WAS NOT PROPERLY CLEANED AS THERE IS RESIDUE AND DEBRIS ON THE DIMPLE OF THE CAPSULE. THE DATA HAS BEEN DOWNLOADED SUCCESSFULLY. 38,491 FRAMES WITH A DURATION OF 19:59:51. ON (B)(6) 2024 - THE INVESTIGATION RESULTS AND THE COMPLETE VIDEO WERE PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 0

    ON (B)(6) 2024 - WE WERE NOTIFIED OF A RETAINED CAPSULE THAT WAS SURGICALLY REMOVED AND COULD NOT BE DOWNLOADED AFTER THE EXTRACTION. FRM-0089C CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN FURTHER INFORMATION. AN RMA WAS ISSUED TO INVESTIGATE THE DEFECTIVE CAPSULE AND DOWNLOAD THE VIDEO. ON (B)(6) 2024 - FRM-0089C WAS RECEIVED INDICATING PATIENT HAD A PRE-EXISTING CONDITION (LAPAROSCOPIC LYSIS OF ADHESIONS IN (B)(6) 2023): THE CUSTOMER ALSO STATED THAT THE CAPSULE WAS SWALLOWED ON (B)(6) 2023 BY REMOTE INGESTION WITHOUT ANY ISSUES, BUT AFTER FOLLOW UPS 2 DAYS AFTER AND 8 DAYS AFTER THEY WERE INFORMED THAT THE CAPSULE HAD NOT BEEN EXCRETED. AFTER TELEHEALTH FOLLOW-UPS ON (B)(6) 2023 WITH NO OBSTRUCTION SYMPTOMS, ON (B)(6) 2024 THE CUSTOMER WAS NOTIFIED THAT THE PATIENT HAD ONGOING PAIN ISSUES. THE PATIENT HAD A PARTIAL OBSTRUCTION CAUSED BY A STRICTURE IN THE ILEUM AS SHOWN IN IMAGING (CT-SCAN). ON (B)(6) 2024 THE PATIENT WENT TO ER WITH AND HAD A DIAGNOSIS OF A PEPTIC ULCER, PATIENT WENT AGAIN ON (B)(6) 2024 AND WAS GIVEN A DIAGNOSIS OF NAUSEA AND VOMITING, ON (B)(6) 2024 THE PATIENT HAD AN EGD INDICATING MODEST PATCHY ANTRAL GASTRITIS AND MODERATE PATCHY DUODENITIS. ON (B)(6) 2024 THE PATIENT WENT TO ER AGAIN WITH ACUTE ABDOMINAL PAIN AND WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2021 WITH A SUSPECTED PARTIAL/LOW-GRADE BOWEL OBSTRUCTION. ON (B)(6) 2024 THE PATIENT WAS PRESCRIBED GASTROGRAFIN AND WAS ADVISED OF SURGERY IF THEY DIDN'T PASS THE CAPSULE. ON (B)(6) 2024 - PATIENT HAD A SURGICAL PROCEDURE WITH CAPSULE REMOVAL. ON (B)(6) 2024 - THE CAPSULE ARRIVED AT CAPSOVISION AND THE INVESTIGATION DETERMINED THAT THERE WAS NO TECHNICAL FAILURES UPON REVIEWING THE VIDEO. THE CAPSULE WAS NOT PROPERLY CLEANED AS THERE IS RESIDUE AND DEBRIS ON THE DIMPLE OF THE CAPSULE. THE DATA HAS BEEN DOWNLOADED SUCCESSFULLY. 38,491 FRAMES WITH A DURATION OF 19:59:51. ON (B)(6) 2024 - THE INVESTIGATION RESULTS AND THE COMPLETE VIDEO WERE PROVIDED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264883 CAPSOCAM SV-3 SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE NEZ CAPSOVISION, INC SV-3 01-23-0061

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention| H