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FDA product code ERL · class 2 · Ear, Nose, Throat
Drill, surgical, ent (electric or pneumatic) including handpiece: medical device reports filed with FDA
29,931 reports carry this product code, 1997–2026; 30 brands with a page.
- 29,931
- reports with this product code
- 0.1% of all MAUDE reports
- 1,514
- reports, 12 months to August 2026
- 1,553 in the 12 months before
- 98.9%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code ERL is FDA's classification for "Drill, surgical, ent (electric or pneumatic) including handpiece" (ear, Nose, Throat panel), a class 2 device. 29,931 medical device reports carry this product code, 0.1% of the MAUDE database, from January 1997 to August 2026.
1,514 reports arrived in the 12 months to August 2026, close to the 1,553 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 malfunction (98.9%) and injury (0.9%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Stryker Instruments-Kalamazoo | 10,174 | 34% |
| Stryker Instruments-A Division Of Stryker | 4,786 | 16% |
| Depuy Synthes Power Tools | 4,211 | 14.1% |
| Depuy Synthes Products | 2,967 | 9.9% |
| Stryker Instruments Kalamazoo | 2,845 | 9.5% |
| Medtronic Xomed | 2,716 | 9.1% |
| The Anspach Effort | 840 | 2.8% |
| Mdt Powered Surgical Solutions | 505 | 1.7% |
| Stryker Instruments | 95 | 0.3% |
| Conmed Linvatec | 54 | 0.2% |
| Gyrus Acmi | 34 | 0.1% |
| Stryker Endoscopy Puerto Rico | 17 | 0.1% |
| Medtronic Navigation | 3 | 0% |
| Medtronic Neurosurgery | 3 | 0% |
| Ethicon Endo Surgery | 2 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Overheating of device | 13,003 | 43.4% |
| Breakthe device broke | 1,562 | 5.2% |
| Device displays incorrect message | 1,294 | 4.3% |
| Detachment of device or device componentpart of the device came off | 1,202 | 4% |
| Device remains activated | 1,115 | 3.7% |
| Excessive heating | 985 | 3.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 902 | 3% |
| Fluid/blood leak | 897 | 3% |
| Noise, audible | 857 | 2.9% |
| Unintended system motionthe device moved when it should not have | 824 | 2.8% |
| Temperature problem | 738 | 2.5% |
| Unintended power up | 737 | 2.5% |
| Vibration | 707 | 2.4% |
| Output below specifications | 656 | 2.2% |
| Leak/splashthe device leaked | 613 | 2% |
| Hole in material | 462 | 1.5% |
| Device inoperablethe device could not be used | 452 | 1.5% |
| Self-activation or keying | 439 | 1.5% |
| Device damaged by another device | 340 | 1.1% |
| Fail-safe problem | 334 | 1.1% |
Questions about drill, surgical, ent (electric or pneumatic) including handpiece reports
What is product code ERL?
FDA's classification code for "Drill, surgical, ent (electric or pneumatic) including handpiece", class 2, reviewed by the ear, Nose, Throat panel. Every device report carries the product code of the device involved.
How many reports carry this code?
29,931 reports through August 2026, 1,514 of them in the latest 12 months.
Which brands appear most often?
Xmax Motor (4,412), Remb Electric Sagittal Saw (1,692), Core Impaction Drill (1,664), S2 Drill (844) and Motor Assembly Xmax (833). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.