Reported Reactions

Devices › Electrosurgical, cutting & coagulation & accessories

Device brand name · Ultrasonic surgical device

THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S: medical device reports filed with FDA

4,590 reports name it, 2017–2026. Manufacturer given most often on reports: Olympus Medical Systems. Product code GEI.

4,590
device reports naming the brand
0% of all MAUDE reports · about 510 a year
403
reports, 12 months to August 2026
494 in the 12 months before
87.5%
classified as malfunction
80.1% across the product code
0%
classified as death, as reported
2 reports · not verified by FDA

4,590 medical device reports received by FDA name the brand "THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S" (ultrasonic surgical device); the manufacturer given most often on reports is Olympus Medical Systems; received from July 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

403 reports arrived in the 12 months to August 2026, down 18% from 494 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 (87.5%) and injury (12.5%); across all electrosurgical, cutting & coagulation & accessories reports (product code GEI) death is recorded in 0.4% and malfunction in 80.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (71.7%), detachment of device or device component (14.9%) and fracture (5.7%). The patient problems coded most often are foreign body in patient, hemorrhage/blood loss/bleeding and appropriate clinical signs, symptoms and conditions term/code not available. 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

03977Sep 2021: 34Oct 2021: 27Nov 2021: 29Dec 2021: 442022Jan 2022: 31Feb 2022: 64Mar 2022: 50Apr 2022: 37May 2022: 34Jun 2022: 54Jul 2022: 26Aug 2022: 54Sep 2022: 35Oct 2022: 71Nov 2022: 40Dec 2022: 622023Jan 2023: 38Feb 2023: 45Mar 2023: 51Apr 2023: 40May 2023: 55Jun 2023: 50Jul 2023: 33Aug 2023: 60Sep 2023: 37Oct 2023: 43Nov 2023: 34Dec 2023: 622024Jan 2024: 48Feb 2024: 44Mar 2024: 49Apr 2024: 37May 2024: 31Jun 2024: 46Jul 2024: 50Aug 2024: 34Sep 2024: 32Oct 2024: 31Nov 2024: 24Dec 2024: 252025Jan 2025: 15Feb 2025: 29Mar 2025: 47Apr 2025: 62May 2025: 50Jun 2025: 53Jul 2025: 69Aug 2025: 57Sep 2025: 50Oct 2025: 65Nov 2025: 53Dec 2025: 772026Jan 2026: 39Feb 2026: 28Mar 2026: 21Apr 2026: 15May 2026: 30Jun 2026: 15Jul 2026: 5Aug 2026: 5

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

03687362017: 10420172018: 53820182019: 73620192020: 50320202021: 36720212022: 55820222023: 54820232024: 45120242025: 62720252026: 1582026

Event type and report source

Event type, as classified on the report

Death0%2
Injury12.5%573
Malfunction87.5%4,015
Other0%0
Not given0%0

Who filed the report

Manufacturer report99.2%4,551
Voluntary report0%0
User facility report0%0
Distributor report0.8%35
Not given0.1%4

Grey bar: all 118,290 reports carrying product code GEI. 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 broke3,29171.7%14%
Detachment of device or device componentpart of the device came off68514.9%3.8%
Fracturea broken bone2635.7%0.7%
Peeled/delaminated2595.6%3%
Material separation2144.7%1.4%
Degraded1162.5%0.3%
Naturally worn591.3%0.1%
Material split, cut or torn471%0.1%
Melted420.9%1.5%
Flaked280.6%0.3%
Activation problem260.6%0.6%
Crackthe device cracked250.5%0.5%
Material fragmentation240.5%0.9%
Material integrity problema problem with the device material230.5%0.6%
Device fell150.3%0.1%
Electrical shorting130.3%0.5%
Communication or transmission problemthe device could not communicate or transmit110.2%1.2%
Scratched material110.2%0.1%
Defective devicethe device was defective90.2%0.6%
Deformation due to compressive stress80.2%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)ReportsShare
Foreign body in patientpart of a device left in the patient731.6%
Hemorrhage/blood loss/bleeding200.4%
Appropriate clinical signs, symptoms and conditions term/code not available80.2%
Device embedded in tissue or plaque70.2%
Fistula60.1%
Bowel perforation50.1%
Blood loss40.1%
Burn(s)a burn40.1%
Injurya physical injury40.1%
No patient involvement40.1%
Abdominal painstomach or belly pain30.1%
Biliary leak20%
Bowel burn20%
Hematomaa collection of blood under the skin or in tissue20%
Perforation20%

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

In context

MeasureTHUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type SProduct code GEIAll MAUDE reports
Reports4,590118,29026,136,888
Share of that pool—3.9%0%
Classified as death, per 1,000 reports049
Classified as injury12.5%16.7%36.2%
Classified as malfunction87.5%80.1%62.3%
Filed by the manufacturer99.2%92.4%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 GEI

BrandReportsLatest 12 monthsClassified as death
LigaSure8,2648790.2%
VasoView Hemopro 26,6336860%
HF unit "ESG-400"2,6986640.1%
Valleylab2,0103530.3%
Vaso View Hemopro1,83800.1%
LigaSure Impact1,831720.3%
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip1,505380.3%
Thunderbeat 5mm 35cm Front-Actuated Grip1,24700.2%
Valleylab Ft101,20320.3%
Vasoview Hemopro1,18700%
Ligasure Advance Pistol Grip97000%
Ligasure Atlas Handswitching 37cm92400.2%
Edge8591710.1%
Force Fx780220.4%
Conmed900890.2%

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 THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S reports

How many FDA reports name THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S?

4,590 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 403 in the latest 12 months.

What kinds of events are reported?

malfunction (87.5%) and injury (12.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (71.7%), detachment of device or device component (14.9%), fracture (5.7%), peeled/delaminated (5.6%) and material separation (4.7%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.2%) and distributor reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S 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.