Devices › Drill, surgical, ent (electric or pneumatic) including handpiece
Device brand name · Drill surgical ent electric or pneumatic i
Ipc Handpiece - Xps Straightshot M4: medical device reports filed with FDA
607 reports name it, 2015–2026. Manufacturer given most often on reports: Medtronic Xomed. Product code ERL.
- 607
- device reports naming the brand
- 0% of all MAUDE reports · about 54 a year
- 45
- reports, 12 months to August 2026
- 62 in the 12 months before
- 98.7%
- classified as malfunction
- 98.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
607 medical device reports received by FDA name the brand "Ipc Handpiece - Xps Straightshot M4" (drill surgical ent electric or pneumatic i); the manufacturer given most often on reports is Medtronic Xomed; received from March 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
45 reports arrived in the 12 months to August 2026, down 27% from 62 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 (98.7%) and injury (1.3%); across all drill, surgical, ent (electric or pneumatic) including handpiece reports (product code ERL) death is recorded in 0% and malfunction in 98.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are overheating of device (88.5%), noise, audible (8.7%) and vibration (8.6%). The patient problems coded most often are no patient involvement, burn(s) and burn, thermal. 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 29,931 reports carrying product code ERL. 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 |
|---|---|---|---|
| Overheating of device | 537 | 88.5% | 43.4% |
| Noise, audible | 53 | 8.7% | 2.9% |
| Vibration | 52 | 8.6% | 2.4% |
| Mechanical jam | 28 | 4.6% | 0.8% |
| Power problem | 12 | 2% | 0.5% |
| Mechanical problema mechanical problem | 11 | 1.8% | 0.6% |
| Device remains activated | 6 | 1% | 3.7% |
| Connection problema connection problem | 5 | 0.8% | 0.2% |
| Display or visual feedback problem | 5 | 0.8% | 0.1% |
| Intermittent loss of power | 4 | 0.7% | 0.1% |
| Intermittent energy output | 3 | 0.5% | 0% |
| Physical resistance/sticking | 3 | 0.5% | 0.2% |
| Self-activation or keying | 3 | 0.5% | 1.5% |
| Activation problem | 2 | 0.3% | 0% |
| Breakthe device broke | 2 | 0.3% | 5.2% |
| Device stops intermittentlythe device stopped now and then | 2 | 0.3% | 0.1% |
| Electrical /electronic property probleman electrical or electronic problem | 2 | 0.3% | 0.2% |
| Excessive heating | 2 | 0.3% | 3.3% |
| Failure to power up | 2 | 0.3% | 0.1% |
| Infusion or flow problema problem with flow or infusion | 2 | 0.3% | 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 | 48 | 7.9% |
| Burn(s)a burn | 1 | 0.2% |
| Burn, thermal | 1 | 0.2% |
| Electric shockan electric shock | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Hypersensitivity/allergic reaction | 1 | 0.2% |
| Injurya physical injury | 1 | 0.2% |
| Intraocular pressure increasedraised pressure in the eye | 1 | 0.2% |
| Intraoperative cardiac valve injury | 1 | 0.2% |
| Superficial (first degree) burn | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ipc Handpiece - Xps Straightshot M4 | Product code ERL | All MAUDE reports |
|---|---|---|---|
| Reports | 607 | 29,931 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 1.3% | 0.9% | 36.2% |
| Classified as malfunction | 98.7% | 98.9% | 62.3% |
| Filed by the manufacturer | 100% | 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."
Other brands with product code ERL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Xmax Motor | 4,447 | 0 | 0% |
| Remb Electric Sagittal Saw | 1,693 | 4 | 0% |
| Core Impaction Drill | 3,913 | 0 | 0% |
| S2 Drill | 844 | 79 | 0% |
| Motor Assembly Xmax | 893 | 14 | 0% |
| Ipc Handpiece - Xps Straightshot M5 | 711 | 124 | 0% |
| Remb Electric Micro Drill | 660 | 9 | 0% |
| Xps Handpiece - Visao | 649 | 12 | 0% |
| Pi Drive Plus Motor | 564 | 0 | 0% |
| Micro Sagittal Saw | 1,395 | 0 | 0% |
| Core Universal Driver | 679 | 0 | 0% |
| ENT Mr8 | 622 | 538 | 0% |
| Pi Drive Motor | 477 | 0 | 0% |
| Core Sumex Drill | 522 | 0 | 0% |
| Straight Irrigating Attachment | 454 | 34 | 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 Ipc Handpiece - Xps Straightshot M4 reports
How many FDA reports name Ipc Handpiece - Xps Straightshot M4?
607 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 45 in the latest 12 months.
What kinds of events are reported?
malfunction (98.7%) and injury (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
overheating of device (88.5%), noise, audible (8.7%), vibration (8.6%), mechanical jam (4.6%) and power problem (2%). 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 Ipc Handpiece - Xps Straightshot M4 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.