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.
84 linked reportsMalfunction 82Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 4.56 |
| 2019-02 | 2 | 4.07 |
| 2019-03 | 1 | 6.92 |
| 2019-04 | 0 | 10.92 |
| 2019-05 | 1 | 10.73 |
| 2019-06 | 0 | 10 |
| 2019-07 | 0 | 8.45 |
| 2019-08 | 0 | 13.22 |
| 2019-09 | 0 | 6.82 |
| 2019-10 | 0 | 7.62 |
| 2019-11 | 1 | 25.4 |
| 2019-12 | 1 | 11.23 |
| 2020-01 | 0 | 12.8 |
| 2020-02 | 0 | 5.92 |
| 2020-03 | 0 | 7.67 |
| 2020-04 | 1 | 7.83 |
| 2020-05 | 0 | 8.67 |
| 2020-06 | 1 | 5.5 |
| 2020-07 | 0 | 11.4 |
| 2020-08 | 0 | 19 |
| 2020-09 | 0 | 8 |
| 2020-10 | 1 | 6 |
| 2020-11 | 0 | 6.9 |
| 2020-12 | 0 | 6.3 |
| 2021-01 | 0 | 6.56 |
| 2021-02 | 0 | 3.92 |
| 2021-03 | 0 | 3.55 |
| 2021-04 | 0 | 6.31 |
| 2021-05 | 0 | 9.33 |
| 2021-06 | 0 | 9.86 |
| 2021-07 | 0 | 11.29 |
| 2021-08 | 0 | 11.58 |
| 2021-09 | 0 | 9.1 |
| 2021-10 | 0 | 12.5 |
| 2021-11 | 0 | 8.75 |
| 2021-12 | 0 | 9.83 |
| 2022-01 | 0 | 11.67 |
| 2022-02 | 0 | 6.3 |
| 2022-03 | 0 | 9.54 |
| 2022-04 | 0 | 8.4 |
| 2022-05 | 0 | 6.5 |
| 2022-06 | 0 | 4.48 |
| 2022-07 | 0 | 4.8 |
| 2022-08 | 0 | 6.43 |
| 2022-09 | 0 | 2.92 |
| 2022-10 | 0 | 6.56 |
| 2022-11 | 0 | 9.8 |
| 2022-12 | 0 | 12.5 |
| 2023-01 | 0 | 6.67 |
| 2023-02 | 0 | 8.7 |
| 2023-03 | 0 | 11.08 |
| 2023-04 | 0 | 9.8 |
| 2023-05 | 0 | 8.5 |
| 2023-06 | 0 | 9.2 |
| 2023-07 | 0 | 8 |
| 2023-08 | 0 | 12.08 |
| 2023-09 | 0 | 13.22 |
| 2023-10 | 0 | 9.75 |
| 2023-11 | 0 | 7.54 |
| 2023-12 | 0 | 12.27 |
| 2024-01 | 0 | 7.33 |
| 2024-02 | 0 | 11.36 |
| 2024-03 | 2 | 10.5 |
| 2024-04 | 0 | 10.42 |
| 2024-05 | 0 | 11.58 |
| 2024-06 | 0 | 10.5 |
| 2024-07 | 0 | 10.82 |
| 2024-08 | 0 | 10.64 |
| 2024-09 | 2 | 12 |
| 2024-10 | 2 | 12 |
| 2024-11 | 4 | 12.31 |
| 2024-12 | 0 | 16.73 |
| 2025-01 | 2 | 14.9 |
| 2025-02 | 0 | 10.7 |
| 2025-03 | 4 | 10.58 |
| 2025-04 | 2 | 10.42 |
| 2025-05 | 6 | 18.58 |
| 2025-06 | 36 | 12.17 |
| 2025-07 | 2 | 8.82 |
| 2025-08 | 0 | 11.7 |
| 2025-09 | 2 | 6.77 |
| 2025-10 | 2 | 9.89 |
| 2025-11 | 2 | 14.8 |
| 2025-12 | 0 | 18 |
| 2026-01 | 0 | 13 |
| 2026-02 | 4 | 9.85 |
| 2026-03 | 0 | 12.4 |
| 2026-04 | 2 | 10.4 |
| 2026-05 | 0 | 7.09 |
| 2026-06 | 0 | 10.7 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2019-02-04 | Z-1011-2019 | Class II | Terminated | Potential esophageal laceration during a patient procedureDistribution: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates. | 483 units ( 325 units US and 158 OUS) | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-23 | 1528319-2026-00036 | Malfunction | Available | catalog number |
| 2026-02-26 | 1528319-2026-00016 | Malfunction | Available | catalog number |
| 2026-02-20 | 1528319-2026-00015 | Malfunction | Available | catalog number |
| 2025-11-18 | 1528319-2025-00106 | Malfunction | Available | catalog number |
| 2025-10-10 | 1528319-2025-00099 | Malfunction | Available | catalog number |
| 2025-09-30 | 1528319-2025-00098 | Malfunction | Available | catalog number |
| 2025-07-24 | 1528319-2025-00080 | Malfunction | Available | catalog number |
| 2025-06-27 | 1528319-2025-00069 | Malfunction | Available | catalog number |
| 2025-06-27 | 1528319-2025-00071 | Malfunction | Available | catalog number |
| 2025-06-27 | 1528319-2025-00070 | Malfunction | Available | catalog number |
| 2025-06-26 | 1528319-2025-00067 | Malfunction | Available | catalog number |
| 2025-06-26 | 1528319-2025-00066 | Malfunction | Available | catalog number |
| 2025-06-25 | 1528319-2025-00064 | Malfunction | Available | catalog number |
| 2025-06-25 | 1528319-2025-00068 | Malfunction | Available | catalog number |
| 2025-06-24 | 1528319-2025-00055 | Malfunction | Available | catalog number |
Showing the most recent 47 of 84 linked reports.
Showing 1–15 of 47
Regulatory clearances
- 510(k)K180689Substantially equivalent (SESE) · 2018-04-12clearance family
- 510(k)K120814Substantially equivalent (SESE) · 2012-09-06clearance family
Predicate lineage
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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