Devices › Instrument, ultrasonic surgical
Device brand name · Instrument ultrasonic surgical
Harmonic ACE: medical device reports filed with FDA
1,636 reports name it, 2006–2026. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code LFL.
- 1,636
- device reports naming the brand
- 0% of all MAUDE reports · about 80 a year
- 680
- reports, 12 months to August 2026
- 8 in the 12 months before
- 97.1%
- classified as malfunction
- 94.9% across the product code
- 0.1%
- classified as death, as reported
- 2 reports · not verified by FDA
1,636 medical device reports received by FDA name the brand "Harmonic ACE" (instrument ultrasonic surgical); the manufacturer given most often on reports is Ethicon Endo-Surgery; received from January 2006 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
680 reports arrived in the 12 months to August 2026, up 8400% from 8 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 (97.1%), injury (2%) and other (0.2%); across all instrument, ultrasonic surgical reports (product code LFL) death is recorded in 0.1% and malfunction in 94.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (21.3%), material separation (17.8%) and failure to read input signal (8.2%). The patient problems coded most often are no patient involvement, foreign body in patient and foreign body, removal of. 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 68,457 reports carrying product code LFL. 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 |
|---|---|---|---|
| Breakthe device broke | 348 | 21.3% | 20.5% |
| Material separation | 291 | 17.8% | 11% |
| Failure to read input signal | 134 | 8.2% | 8.2% |
| Detachment of device component | 108 | 6.6% | 6.9% |
| Device displays incorrect message | 99 | 6.1% | 10.7% |
| Detachment of device or device componentpart of the device came off | 93 | 5.7% | 6.8% |
| Device inoperablethe device could not be used | 88 | 5.4% | 3.1% |
| Difficult or delayed activation | 86 | 5.3% | 2.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 66 | 4% | 2.7% |
| Activation, positioning or separation problem | 56 | 3.4% | 1% |
| Component falling | 36 | 2.2% | 3.9% |
| Melted | 35 | 2.1% | 1.4% |
| Material integrity problema problem with the device material | 31 | 1.9% | 1.6% |
| Replace | 24 | 1.5% | 13.3% |
| Delivered as unsterile product | 18 | 1.1% | 0.4% |
| Failure to cut | 16 | 1% | 1.1% |
| Inappropriate or unexpected reset | 13 | 0.8% | 0.7% |
| Defective devicethe device was defective | 12 | 0.7% | 0.6% |
| Insufficient device problem information | 12 | 0.7% | 1.2% |
| Device issuea problem with the device | 11 | 0.7% | 3.9% |
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 | 12 | 0.7% |
| Foreign body in patientpart of a device left in the patient | 11 | 0.7% |
| Foreign body, removal of | 9 | 0.6% |
| Device embedded in tissue or plaque | 7 | 0.4% |
| Hemorrhage/blood loss/bleeding | 7 | 0.4% |
| Therapy/non-surgical treatment, additional | 5 | 0.3% |
| Failure to anastomose | 4 | 0.2% |
| Blood loss | 3 | 0.2% |
| Burn, thermal | 3 | 0.2% |
| Deaththe patient died; cause not stated by this term | 2 | 0.1% |
| Low blood pressure/ hypotension | 2 | 0.1% |
| Nonresorbable materials, unretrieved in body | 2 | 0.1% |
| Not applicable | 2 | 0.1% |
| Painpain, site not specified | 2 | 0.1% |
| Blurred vision | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Harmonic ACE | Product code LFL | All MAUDE reports |
|---|---|---|---|
| Reports | 1,636 | 68,457 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 1 | 1 | 9 |
| Classified as injury | 2% | 4.5% | 36.2% |
| Classified as malfunction | 97.1% | 94.9% | 62.3% |
| Filed by the manufacturer | 64.8% | 96.8% | 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 LFL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Ultracision Harmonic Ace | 9,358 | 0 | 0% |
| Harmonic Ace Plus 7 Adv Hemostasis 36 | 6,831 | 537 | 0% |
| Harmonic Hd 1000i Shears 36cm Shaft | 5,033 | 196 | 0% |
| Harmonic Lap 5mm Shear 36cm | 2,720 | 88 | 0% |
| Harmonic Ace 36 Cm | 2,598 | 0 | 0.1% |
| Harmonic Ace 36cm W Erg Handle | 2,341 | 0 | 0% |
| Sonicision | 1,809 | 139 | 0.2% |
| Harmonic Scalpel Ultracision Hand Piece | 1,677 | 0 | 0.1% |
| SONICBEAT 5 mm, 35 cm, Front-actuated Grip | 1,640 | 373 | 0% |
| Harmonic 1100 Shears 36cm | 1,434 | 203 | 0.1% |
| Ultracision Harmonic Scalpel Hand Piece | 1,430 | 0 | 0% |
| Harmonic Scalpel Hand Piece | 1,365 | 23 | 0% |
| Ultracision Surg Dev Curved Shears Endo | 1,586 | 0 | 0% |
| Harmonic Scalpel Ultracision Laparosonic Coagulating She | 1,067 | 0 | 0.1% |
| Harmonic Ace + 7 | 957 | 0 | 0.2% |
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 Harmonic ACE reports
How many FDA reports name Harmonic ACE?
1,636 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 680 in the latest 12 months.
What kinds of events are reported?
malfunction (97.1%), injury (2%) and other (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (21.3%), material separation (17.8%), failure to read input signal (8.2%), detachment of device component (6.6%) and device displays incorrect message (6.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (64.8%) and voluntary reports (2.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Harmonic ACE 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.