Reported Reactions

Devices › Instrument, ultrasonic surgical

Device brand name · Instrument

Sonicbeat 5 Mm 20 Cm Front-Actuated Grip: medical device reports filed with FDA

167 reports name it, 2017–2026. Manufacturer given most often on reports: Olympus Medical Systems. Product code LFL.

167
device reports naming the brand
0% of all MAUDE reports · about 18 a year
16
reports, 12 months to August 2026
19 in the 12 months before
97.6%
classified as malfunction
94.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 167 reports that name the brand "Sonicbeat 5 Mm 20 Cm Front-Actuated Grip" (instrument), received between January 2017 and June 2026; the manufacturer given most often on reports is Olympus Medical Systems. Spellings of one product vary from report to report.

16 reports arrived in the 12 months to August 2026, down 16% from 19 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 (97.6%) and injury (2.4%); 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 (62.3%), material separation (8.4%) and peeled/delaminated (7.2%). The patient problems coded most often are burn(s), paralysis and seroma. 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

024Sep 2021: 1Oct 2021: 0Nov 2021: 0Dec 2021: 12022Jan 2022: 0Feb 2022: 1Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 1Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 1Dec 2022: 22023Jan 2023: 0Feb 2023: 0Mar 2023: 1Apr 2023: 0May 2023: 2Jun 2023: 4Jul 2023: 1Aug 2023: 2Sep 2023: 0Oct 2023: 0Nov 2023: 1Dec 2023: 22024Jan 2024: 0Feb 2024: 0Mar 2024: 3Apr 2024: 0May 2024: 2Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 4Oct 2024: 1Nov 2024: 1Dec 2024: 12025Jan 2025: 2Feb 2025: 4Mar 2025: 0Apr 2025: 0May 2025: 2Jun 2025: 3Jul 2025: 0Aug 2025: 1Sep 2025: 1Oct 2025: 1Nov 2025: 2Dec 2025: 32026Jan 2026: 1Feb 2026: 2Mar 2026: 0Apr 2026: 3May 2026: 0Jun 2026: 3Jul 2026: 0Aug 2026: 0

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

018362017: 1720172018: 2520182019: 3620192020: 2320202021: 820212022: 520222023: 1320232024: 1220242025: 1920252026: 92026

Event type and report source

Event type, as classified on the report

Death0%0
Injury2.4%4
Malfunction97.6%163
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%167
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Breakthe device broke10462.3%20.5%
Material separation148.4%11%
Peeled/delaminated127.2%1%
Degraded84.8%0.2%
Detachment of device or device componentpart of the device came off74.2%6.8%
Crackthe device cracked21.2%0.6%
Material fragmentation21.2%0.3%
Material deformation10.6%0.1%
Material split, cut or torn10.6%0.1%
Naturally worn10.6%0.2%
Output problem10.6%0.3%
Thermal decomposition of device10.6%0.5%

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)ReportsShare
Burn(s)a burn10.6%
Paralysis10.6%
Seromaa collection of fluid under the skin10.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureSonicbeat 5 Mm 20 Cm Front-Actuated GripProduct code LFLAll MAUDE reports
Reports16768,45726,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports019
Classified as injury2.4%4.5%36.2%
Classified as malfunction97.6%94.9%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Ultracision Harmonic Ace9,35800%
Harmonic Ace Plus 7 Adv Hemostasis 366,8315370%
Harmonic Hd 1000i Shears 36cm Shaft5,0331960%
Harmonic Lap 5mm Shear 36cm2,720880%
Harmonic Ace 36 Cm2,59800.1%
Harmonic Ace 36cm W Erg Handle2,34100%
Sonicision1,8091390.2%
Harmonic Scalpel Ultracision Hand Piece1,67700.1%
SONICBEAT 5 mm, 35 cm, Front-actuated Grip1,6403730%
Harmonic ACE1,6366800.1%
Harmonic 1100 Shears 36cm1,4342030.1%
Ultracision Harmonic Scalpel Hand Piece1,43000%
Harmonic Scalpel Hand Piece1,365230%
Ultracision Surg Dev Curved Shears Endo1,58600%
Harmonic Scalpel Ultracision Laparosonic Coagulating She1,06700.1%

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 Sonicbeat 5 Mm 20 Cm Front-Actuated Grip reports

How many FDA reports name Sonicbeat 5 Mm 20 Cm Front-Actuated Grip?

167 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 16 in the latest 12 months.

What kinds of events are reported?

malfunction (97.6%) and injury (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (62.3%), material separation (8.4%), peeled/delaminated (7.2%), degraded (4.8%) and detachment of device or device component (4.2%). 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 Sonicbeat 5 Mm 20 Cm Front-Actuated Grip 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.