Devices › Orthopedic stereotaxic instrument
Device brand name · Stereotaxic device robotics
Handpiece MICS: medical device reports filed with FDA
812 reports name it, 2016–2026. Manufacturer given most often on reports: Mako Surgical. Product code OLO.
- 812
- device reports naming the brand
- 0% of all MAUDE reports · about 81 a year
- 183
- reports, 12 months to August 2026
- 70 in the 12 months before
- 99%
- classified as malfunction
- 81.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 812 reports that name the brand "Handpiece MICS" (stereotaxic device robotics), received between June 2016 and August 2026; the manufacturer given most often on reports is Mako Surgical. Spellings of one product vary from report to report.
183 reports arrived in the 12 months to August 2026, up 161% from 70 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 malfunction (99%) and injury (1%); across all orthopedic stereotaxic instrument reports (product code OLO) death is recorded in 0.1% and malfunction in 81.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (56.9%), mechanical problem (25.4%) and non reproducible results (16.4%). The patient problems coded most often are no patient involvement, damage to ligament(s) and foreign body in patient. 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 20,634 reports carrying product code OLO. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 462 | 56.9% | 7.2% |
| Mechanical problema mechanical problem | 206 | 25.4% | 9.2% |
| Non reproducible results | 133 | 16.4% | 2.1% |
| Insufficient device problem information | 43 | 5.3% | 4.4% |
| Breakthe device broke | 41 | 5% | 10.3% |
| Failure to calibrate | 28 | 3.4% | 0.7% |
| Output problem | 27 | 3.3% | 1.4% |
| Complete loss of power | 26 | 3.2% | 0.4% |
| Residue after decontamination | 23 | 2.8% | 0.8% |
| Intermittent loss of power | 19 | 2.3% | 0.2% |
| Electrical /electronic property probleman electrical or electronic problem | 16 | 2% | 0.5% |
| Material integrity problema problem with the device material | 15 | 1.8% | 6.2% |
| Computer software problema software problem | 14 | 1.7% | 2.7% |
| Mechanical jam | 14 | 1.7% | 1.6% |
| Fracturea broken bone | 13 | 1.6% | 3.1% |
| Electrical power problem | 12 | 1.5% | 0.1% |
| Difficult to insertthe device was hard to insert | 11 | 1.4% | 0.3% |
| Migration or expulsion of device | 11 | 1.4% | 0.1% |
| Application program problem: parameter calculation error | 10 | 1.2% | 2.9% |
| Physical resistance/sticking | 9 | 1.1% | 1.3% |
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 |
|---|---|---|
| No patient involvement | 4 | 0.5% |
| Damage to ligament(s) | 1 | 0.1% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.1% |
| Laceration(s) | 1 | 0.1% |
| Muscle/tendon damage | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Handpiece MICS | Product code OLO | All MAUDE reports |
|---|---|---|---|
| Reports | 812 | 20,634 | 26,136,888 |
| Share of that pool | — | 3.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 1% | 18.2% | 36.2% |
| Classified as malfunction | 99% | 81.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 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 OLO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Mazor X System | 1,009 | 238 | 0.6% |
| Real Intelligence Cori | 983 | 97 | 0% |
| 3 0 Rio Robotic Arm - Mics | 847 | 2 | 0% |
| Reamer Handle Offset | 758 | 345 | 0% |
| Velys Saw Interface Right | 611 | 124 | 0% |
| Velys Saw Interface Left | 597 | 125 | 0% |
| Excelsius Gps | 597 | 128 | 0.3% |
| Real Intelligence Robotic Drill | 585 | 81 | 0% |
| Navio Handpiece | 489 | 0 | 0% |
| NavLock | 464 | 90 | 0% |
| Velys Satellite Station | 353 | 94 | 0% |
| Navio Surgical System Us | 334 | 0 | 0% |
| Mako Robotic Arm 3 1 | 317 | 65 | 0% |
| Velys Saw Handpiece | 269 | 82 | 0% |
| Velys | 257 | 257 | 0% |
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 Handpiece MICS reports
How many FDA reports name Handpiece MICS?
812 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 183 in the latest 12 months.
What kinds of events are reported?
malfunction (99%) and injury (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (56.9%), mechanical problem (25.4%), non reproducible results (16.4%), insufficient device problem information (5.3%) and break (5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Handpiece MICS 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.