Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
6 linked reportsInjury 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.4 |
| 2019-02 | 0 | 1.29 |
| 2019-03 | 0 | 1.33 |
| 2019-04 | 0 | 2 |
| 2019-06 | 0 | 1.33 |
| 2019-07 | 1 | 1.25 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 2.5 |
| 2020-01 | 0 | 1 |
| 2020-03 | 0 | 1.67 |
| 2020-05 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-03 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-06 | 2 | 2.33 |
| 2021-07 | 0 | 1.4 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 1 | 1.2 |
| 2022-05 | 0 | 2.5 |
| 2022-07 | 0 | 1 |
| 2022-08 | 0 | 1 |
| 2022-09 | 0 | 2 |
| 2022-10 | 2 | 2.67 |
| 2022-11 | 0 | 1 |
| 2023-01 | 0 | 1 |
| 2023-03 | 0 | 1.67 |
| 2023-04 | 0 | 1.5 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 1.5 |
| 2023-07 | 0 | 2 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-02 | 0 | 1.5 |
| 2024-03 | 0 | 1 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 1 |
| 2024-06 | 0 | 14.5 |
| 2024-07 | 0 | 15 |
| 2024-08 | 0 | 4.33 |
| 2024-09 | 0 | 9.5 |
| 2024-10 | 0 | 3.8 |
| 2024-11 | 0 | 2.33 |
| 2024-12 | 0 | 4.67 |
| 2025-01 | 0 | 2.33 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 4.33 |
| 2025-06 | 0 | 3 |
| 2025-07 | 0 | 3.67 |
| 2025-08 | 0 | 2 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 3.33 |
| 2025-11 | 0 | 2.67 |
| 2025-12 | 0 | 3.25 |
| 2026-01 | 0 | 1.5 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 5 |
| 2026-04 | 0 | 1.25 |
| 2026-05 | 0 | 1 |
| 2026-06 | 0 | 1.33 |
Failure-mode summaryAI-generated
6 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-02-26 | Z-2536-2020 | Class II | Terminated | Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.Distribution: US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA. | 82 | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-10-19 | 3008062894-2022-00003 | Injury | Available | catalog number |
| 2022-10-19 | 3008062894-2022-00002 | Injury | Available | catalog number |
| 2022-04-14 | 3008062894-2022-00001 | Injury | Available | catalog number |
| 2021-06-25 | 3008062894-2021-00001 | Injury | Available | catalog number |
| 2021-06-25 | 3008062894-2021-00002 | Injury | Available | catalog number |
| 2019-07-26 | 3008062894-2019-00001 | Injury | Available | catalog number |
Regulatory clearances
- 510(k)K242643Substantially equivalent (SESE) · 2024-12-04clearance family
- 510(k)K192662Substantially equivalent (SESE) · 2020-02-14clearance family
Predicate lineage
- K192662
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
None in the loaded window.
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