Devices › Device types
FDA product code LFL · class U · Unknown
Instrument, ultrasonic surgical: medical device reports filed with FDA
68,457 reports carry this product code, 1995–2026; 30 brands with a page.
- 68,457
- reports with this product code
- 0.3% of all MAUDE reports
- 3,979
- reports, 12 months to August 2026
- 4,009 in the 12 months before
- 94.9%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code LFL is FDA's classification for "Instrument, ultrasonic surgical" (unknown panel), a class U device. 68,457 medical device reports carry this product code, 0.3% of the MAUDE database, from August 1995 to August 2026.
3,979 reports arrived in the 12 months to August 2026, close to the 4,009 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 (94.9%), injury (4.5%) and death (0.1%). 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 |
|---|---|---|
| Ethicon Endo-Surgery | 45,501 | 66.5% |
| Ethicon Endo-Surgery Cincinnati | 4,077 | 6% |
| Ethicon Endo Surgery Cincinnati | 3,925 | 5.7% |
| Ethicon Endo-Surgery - Alb | 1,721 | 2.5% |
| Olympus Medical Systems | 1,715 | 2.5% |
| Covidien Mfg Dc Boulder | 1,558 | 2.3% |
| Integra Lifesciences Ireland | 1,163 | 1.7% |
| Aomori Olympus | 1,004 | 1.5% |
| Ethicon Endo Surgery | 578 | 0.8% |
| Covidien | 498 | 0.7% |
| North Haven - Uss | 415 | 0.6% |
| United States Surgical | 398 | 0.6% |
| Johnson & Johnson Medical Suzhou | 391 | 0.6% |
| Stryker Instruments-A Division Of Stryker | 226 | 0.3% |
| Covidien Formerly US Surgical | 104 | 0.2% |
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 |
|---|---|---|
| Breakthe device broke | 14,007 | 20.5% |
| Replace | 9,073 | 13.3% |
| Material separation | 7,499 | 11% |
| Device displays incorrect message | 7,358 | 10.7% |
| Failure to read input signal | 5,631 | 8.2% |
| Detachment of device component | 4,739 | 6.9% |
| Detachment of device or device componentpart of the device came off | 4,629 | 6.8% |
| Device issuea problem with the device | 2,704 | 3.9% |
| Component falling | 2,698 | 3.9% |
| Device inoperablethe device could not be used | 2,126 | 3.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 1,824 | 2.7% |
| Difficult or delayed activation | 1,691 | 2.5% |
| Sticking | 1,659 | 2.4% |
| Noise | 1,372 | 2% |
| Component(s), broken | 1,140 | 1.7% |
| Material integrity problema problem with the device material | 1,072 | 1.6% |
| Melted | 961 | 1.4% |
| Overheating of device | 829 | 1.2% |
| Tip breakage | 829 | 1.2% |
| Insufficient device problem information | 794 | 1.2% |
Questions about instrument, ultrasonic surgical reports
What is product code LFL?
FDA's classification code for "Instrument, ultrasonic surgical", class U, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
68,457 reports through August 2026, 3,979 of them in the latest 12 months.
Which brands appear most often?
Ultracision Harmonic Ace (9,356), Harmonic Ace Plus 7 Adv Hemostasis 36 (6,831), Harmonic Hd 1000i Shears 36cm Shaft (5,033), Harmonic Lap 5mm Shear 36cm (2,720) and Harmonic Ace 36 Cm (2,597). 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.