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.
19 linked reportsMalfunction 16Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 21.43 |
| 2019-02 | 0 | 18.76 |
| 2019-03 | 0 | 17.38 |
| 2019-04 | 0 | 19.33 |
| 2019-05 | 0 | 13.96 |
| 2019-06 | 0 | 13.78 |
| 2019-07 | 0 | 13.72 |
| 2019-08 | 0 | 17.95 |
| 2019-09 | 0 | 18.36 |
| 2019-10 | 1 | 18.02 |
| 2019-11 | 0 | 15.86 |
| 2019-12 | 1 | 17.13 |
| 2020-01 | 2 | 16.71 |
| 2020-02 | 0 | 20.62 |
| 2020-03 | 0 | 18.02 |
| 2020-04 | 0 | 17.91 |
| 2020-05 | 0 | 18.04 |
| 2020-06 | 0 | 23 |
| 2020-07 | 0 | 18.62 |
| 2020-08 | 0 | 16.63 |
| 2020-09 | 0 | 17.67 |
| 2020-10 | 0 | 14.94 |
| 2020-11 | 0 | 24.82 |
| 2020-12 | 0 | 22.21 |
| 2021-01 | 0 | 15.96 |
| 2021-02 | 1 | 16.49 |
| 2021-03 | 0 | 19.12 |
| 2021-04 | 0 | 15.19 |
| 2021-05 | 2 | 15.95 |
| 2021-06 | 0 | 19 |
| 2021-07 | 0 | 16.37 |
| 2021-08 | 0 | 18 |
| 2021-09 | 0 | 23.38 |
| 2021-10 | 0 | 22.3 |
| 2021-11 | 0 | 22.43 |
| 2021-12 | 0 | 30.38 |
| 2022-01 | 0 | 17.63 |
| 2022-02 | 2 | 20.54 |
| 2022-03 | 0 | 24.04 |
| 2022-04 | 0 | 20.64 |
| 2022-05 | 1 | 19.24 |
| 2022-06 | 0 | 25.56 |
| 2022-07 | 0 | 14.88 |
| 2022-08 | 1 | 22.97 |
| 2022-09 | 0 | 23.4 |
| 2022-10 | 1 | 24.15 |
| 2022-11 | 0 | 27.41 |
| 2022-12 | 0 | 24.35 |
| 2023-01 | 0 | 25.31 |
| 2023-02 | 0 | 18 |
| 2023-03 | 0 | 17.71 |
| 2023-04 | 0 | 24.73 |
| 2023-05 | 0 | 20.82 |
| 2023-06 | 0 | 21.58 |
| 2023-07 | 0 | 19.96 |
| 2023-08 | 0 | 18.26 |
| 2023-09 | 0 | 17.14 |
| 2023-10 | 1 | 20.16 |
| 2023-11 | 0 | 16.89 |
| 2023-12 | 0 | 23.32 |
| 2024-01 | 0 | 18.64 |
| 2024-02 | 0 | 16.59 |
| 2024-03 | 0 | 13.58 |
| 2024-04 | 0 | 14.97 |
| 2024-05 | 0 | 12.78 |
| 2024-06 | 0 | 18.13 |
| 2024-07 | 0 | 13.33 |
| 2024-08 | 0 | 15.55 |
| 2024-09 | 0 | 17.28 |
| 2024-10 | 0 | 12.35 |
| 2024-11 | 0 | 11.41 |
| 2024-12 | 0 | 16.73 |
| 2025-01 | 0 | 13.56 |
| 2025-02 | 0 | 13.63 |
| 2025-03 | 0 | 12.54 |
| 2025-04 | 0 | 11.36 |
| 2025-05 | 0 | 16.95 |
| 2025-06 | 0 | 13.06 |
| 2025-07 | 0 | 18 |
| 2025-08 | 0 | 17.47 |
| 2025-09 | 0 | 14.61 |
| 2025-10 | 0 | 11.11 |
| 2025-11 | 0 | 10.08 |
| 2025-12 | 0 | 16.79 |
| 2026-01 | 4 | 14.68 |
| 2026-02 | 0 | 15.06 |
| 2026-03 | 2 | 11.26 |
| 2026-04 | 0 | 12.27 |
| 2026-05 | 0 | 12.42 |
| 2026-06 | 0 | 16.46 |
Failure-mode summaryAI-generated
19 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-11-12 | Z-0332-2022 | Class II | Open, Classified | Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuitDistribution: Brazil | 2 units OUS | clearance family |
| 2021-06-23 | Z-2240-2021 | Class II | Terminated | Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is locatedDistribution: US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA. | 96 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-16 | 1717344-2026-00375 | Malfunction | Available | exact di |
| 2026-01-28 | 1717344-2026-00123 | Malfunction | Available | exact di |
| 2026-01-08 | 1717344-2026-00047 | Malfunction | Available | exact di |
| 2023-10-17 | 1717344-2023-01277 | Malfunction | Available | exact di |
| 2022-10-03 | 1717344-2022-01227 | Malfunction | Available | exact di |
| 2022-08-18 | 1717344-2022-00994 | Malfunction | Available | exact di |
| 2022-05-09 | 1717344-2022-00562 | Malfunction | Available | exact di |
| 2022-02-16 | 13541453 | Malfunction | Available | exact di |
| 2021-05-18 | 1717344-2021-00735 | Injury | Available | exact di |
| 2021-05-11 | 1717344-2021-00698 | Injury | Available | exact di |
| 2021-02-23 | 1717344-2021-00284 | Malfunction | Available | exact di |
| 2020-01-28 | 1717344-2020-00080 | Malfunction | Available | exact di |
| 2020-01-08 | 1717344-2020-00035 | Malfunction | Available | exact di |
| 2019-12-23 | 9510477 | Malfunction | Available | model number |
| 2019-10-01 | 1717344-2019-01236 | Injury | Available | exact di |
Showing the most recent 15 of 19 linked reports.
Regulatory clearances
- 510(k)K180149Substantially equivalent (SESE) · 2018-03-26clearance 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
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2011-10-04 | WL | Warning Letter | Oridion Medical 1987 Ltd. | — |
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