Device brand name · Lecd thermal ablation system
Nanoknife System: medical device reports filed with FDA
198 reports name it, 2012–2024. Manufacturer given most often on reports: Angiodynamics.
- 198
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 28.3%
- classified as malfunction
- 62.3% across all reports
- 2.5%
- classified as death, as reported
- 5 reports · not verified by FDA
198 medical device reports received by FDA name the brand "Nanoknife System" (lecd thermal ablation system); the manufacturer given most often on reports is Angiodynamics; received from May 2012 to July 2024. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (69.2%), malfunction (28.3%) and death (2.5%). Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (31.3%), device operates differently than expected (10.6%) and device displays incorrect message (4%). The patient problems coded most often are pneumothorax, tachycardia and high blood pressure/ hypertension. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Insufficient device problem information | 62 | 31.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 21 | 10.6% |
| Device displays incorrect message | 8 | 4% |
| Migration or expulsion of device | 8 | 4% |
| Communication or transmission problemthe device could not communicate or transmit | 5 | 2.5% |
| Loss of powerthe device lost power | 4 | 2% |
| Application interface becomes non-functional or program exits abnormally | 3 | 1.5% |
| Electrical /electronic property probleman electrical or electronic problem | 3 | 1.5% |
| Failure of device to self-test | 3 | 1.5% |
| Improper or incorrect procedure or method | 3 | 1.5% |
| Arcing of electrodes | 2 | 1% |
| Computer operating system problem | 2 | 1% |
| Malposition of device | 2 | 1% |
| Noise, audible | 2 | 1% |
| Charging problem | 1 | 0.5% |
| Computer software problema software problem | 1 | 0.5% |
| Detachment of device component | 1 | 0.5% |
| Device disinfection or sterilization issue | 1 | 0.5% |
| Device inoperablethe device could not be used | 1 | 0.5% |
| Device remains activated | 1 | 0.5% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Pneumothoraxa collapsed lung | 17 | 8.6% |
| Tachycardiafast heart rate | 17 | 8.6% |
| High blood pressure/ hypertension | 10 | 5.1% |
| Atrial fibrillationan irregular heart rhythm | 8 | 4% |
| Hemorrhage/blood loss/bleeding | 8 | 4% |
| Painpain, site not specified | 5 | 2.5% |
| Tissue damage | 4 | 2% |
| Urinary retentionbeing unable to empty the bladder | 3 | 1.5% |
| Bradycardiaslow heart rate | 2 | 1% |
| Dyspneashortness of breath | 2 | 1% |
| Hematuria | 2 | 1% |
| Hyperbilirubinemia | 2 | 1% |
| Incontinence | 2 | 1% |
| Paralysis | 2 | 1% |
| Tissue breakdown | 2 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Nanoknife System | All MAUDE reports |
|---|---|---|
| Reports | 198 | 26,136,888 |
| Share of that pool | — | 0% |
| Classified as death, per 1,000 reports | 25 | 9 |
| Classified as injury | 69.2% | 36.2% |
| Classified as malfunction | 28.3% | 62.3% |
| Filed by the manufacturer | 99.5% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Questions about Nanoknife System reports
How many FDA reports name Nanoknife System?
198 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (69.2%), malfunction (28.3%) and death (2.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (31.3%), device operates differently than expected (10.6%), device displays incorrect message (4%), migration or expulsion of device (4%) and communication or transmission problem (2.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.5%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Nanoknife System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.