Devices › Unit, operative dental
Device brand name · Unit operative dental
Tps Handpiece Cord: medical device reports filed with FDA
580 reports name it, 2010–2016. Manufacturer given most often on reports: Stryker Instruments-Kalamazoo. Product code EIA.
- 580
- device reports naming the brand
- 0% of all MAUDE reports · about 35 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.5%
- classified as malfunction
- 97.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 580 reports that name the brand "Tps Handpiece Cord" (unit operative dental), received between January 2010 and August 2016; the manufacturer given most often on reports is Stryker Instruments-Kalamazoo. Spellings of one product vary from report to report.
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 malfunction (99.5%) and injury (0.5%); across all unit, operative dental reports (product code EIA) death is recorded in 0% and malfunction in 97.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device displays incorrect message (54.5%), self-activation or keying (11.4%) and device operates differently than expected (9%). The patient problems coded most often are no patient involvement, burn(s) and electric shock. 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
No report naming Tps Handpiece Cord was received in the five years to August 2026; the latest was received in August 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,409 reports carrying product code EIA. 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 displays incorrect message | 316 | 54.5% | 13.3% |
| Self-activation or keying | 66 | 11.4% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 52 | 9% | 4.3% |
| Overheating of device | 40 | 6.9% | 24.3% |
| Unintended system motionthe device moved when it should not have | 38 | 6.6% | 0.3% |
| Device remains activated | 26 | 4.5% | 5.7% |
| Unintended power up | 24 | 4.1% | 6% |
| Cut in material | 14 | 2.4% | 1.1% |
| Unintended movement | 12 | 2.1% | 1.1% |
| Electrical /electronic property probleman electrical or electronic problem | 9 | 1.6% | 1.6% |
| Failure to shut off | 4 | 0.7% | 0% |
| Smoking | 3 | 0.5% | 0.5% |
| Temperature problem | 3 | 0.5% | 0.2% |
| Device damaged by another device | 2 | 0.3% | 0.1% |
| Disassembly | 2 | 0.3% | 3.9% |
| Material protrusion/extrusion | 2 | 0.3% | 0% |
| Breakthe device broke | 1 | 0.2% | 1.6% |
| Component missing | 1 | 0.2% | 2% |
| Device-device incompatibility | 1 | 0.2% | 0% |
| Image display error/artifact | 1 | 0.2% | 0% |
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 | 407 | 70.2% |
| Burn(s)a burn | 3 | 0.5% |
| Electric shockan electric shock | 1 | 0.2% |
| Laceration(s) | 1 | 0.2% |
| Painpain, site not specified | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Tps Handpiece Cord | Product code EIA | All MAUDE reports |
|---|---|---|---|
| Reports | 580 | 1,409 | 26,136,888 |
| Share of that pool | — | 41.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.5% | 2.5% | 36.2% |
| Classified as malfunction | 99.5% | 97.3% | 62.3% |
| Filed by the manufacturer | 100% | 98.7% | 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 EIA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Universal Handswitch | 345 | 0 | 0% |
| Micro Drill Medium Straight Attachment | 312 | 0 | 0% |
| Micro Sagittal Saw | 1,395 | 0 | 0% |
| Micro Oscillating Saw | 346 | 0 | 0% |
| Micro Drill | 190 | 0 | 0% |
| Micro Reciprocating Saw | 376 | 0 | 0% |
| Core Micro Drill | 670 | 0 | 0% |
| Elite 12cm Straight Attachment | 236 | 12 | 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 Tps Handpiece Cord reports
How many FDA reports name Tps Handpiece Cord?
580 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?
malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (54.5%), self-activation or keying (11.4%), device operates differently than expected (9%), overheating of device (6.9%) and unintended system motion (6.6%). 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 Tps Handpiece Cord 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.