Devices › Stimulator, low electric field, tumor treatment
Device brand name · Optune gio
Optune Gio: medical device reports filed with FDA
560 reports name it, 2024–2026. Manufacturer given most often on reports: Novocure. Product code NZK.
- 560
- device reports naming the brand
- 0% of all MAUDE reports · about 225 a year
- 245
- reports, 12 months to August 2026
- 236 in the 12 months before
- 0.2%
- classified as malfunction
- 0.1% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
560 medical device reports received by FDA name the brand "Optune Gio" (optune gio); the manufacturer given most often on reports is Novocure; received from January 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
245 reports arrived in the 12 months to August 2026, close to the 236 of 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 (99.6%), death (0.2%) and malfunction (0.2%); across all stimulator, low electric field, tumor treatment reports (product code NZK) death is recorded in 3.3% and malfunction in 0.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device-device incompatibility (0.2%), inappropriate/inadequate shock/stimulation (0.2%) and insufficient device problem information (0.2%). The patient problems coded most often are skin inflammation/ irritation, laceration(s) and wound dehiscence. 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 811 reports carrying product code NZK. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device-device incompatibility | 1 | 0.2% | 0.1% |
| Inappropriate/inadequate shock/stimulation | 1 | 0.2% | 0.1% |
| Insufficient device problem information | 1 | 0.2% | 2.3% |
| Material erosion | 1 | 0.2% | 0.1% |
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 |
|---|---|---|
| Skin inflammation/ irritation | 157 | 28% |
| Laceration(s) | 81 | 14.5% |
| Wound dehiscencea wound reopened | 65 | 11.6% |
| Post operative wound infection | 52 | 9.3% |
| Skin infection | 43 | 7.7% |
| Falla fall | 29 | 5.2% |
| Ulcer | 26 | 4.6% |
| Headachehead pain | 25 | 4.5% |
| Hypersensitivity/allergic reaction | 22 | 3.9% |
| Convulsion/seizure | 12 | 2.1% |
| Cellulitisa skin infection | 11 | 2% |
| Impaired healingslow healing | 9 | 1.6% |
| Back painback pain | 8 | 1.4% |
| Abscessa collection of pus | 7 | 1.3% |
| Arthralgiajoint pain | 7 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Optune Gio | Product code NZK | All MAUDE reports |
|---|---|---|---|
| Reports | 560 | 811 | 26,136,888 |
| Share of that pool | — | 69.1% | 0% |
| Classified as death, per 1,000 reports | 2 | 33 | 9 |
| Classified as injury | 99.6% | 94.7% | 36.2% |
| Classified as malfunction | 0.2% | 0.1% | 62.3% |
| Filed by the manufacturer | 99.8% | 99.6% | 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."
Other brands with product code NZK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Optune | 202 | 0 | 2% |
Ordered by report count for navigation only. 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 also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Optune Gio reports
How many FDA reports name Optune Gio?
560 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 245 in the latest 12 months.
What kinds of events are reported?
injury (99.6%), death (0.2%) and malfunction (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device-device incompatibility (0.2%), inappropriate/inadequate shock/stimulation (0.2%), insufficient device problem information (0.2%) and material erosion (0.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Optune Gio 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.