Lithotriptor, ultrasonic: medical device reports filed with FDA

1,241 reports carry this product code, 1994–2026; 6 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,241
reports with this product code: 0% of all MAUDE reports; 378
reports, 12 months to August 2026: 309 in the 12 months before; 95.2%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code FEO is FDA's classification for "Lithotriptor, ultrasonic" (gastroenterology, Urology panel), a class 2 device. 1,241 medical device reports carry this product code, 0% of the MAUDE database, from March 1994 to August 2026.

378 reports arrived in the 12 months to August 2026, up 22% from 309 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 (95.2%), injury (3.5%) and other (0.8%). 6 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Shockpulse Lithotripsy Transducer	467	169	0%	99.4%
Shockpulse-Se Lithotripsy System	269	89	0%	97.4%
Shockpulse-Se Lithotripsy System Reusab	205	73	0%	97.6%
Single Use Mechanical Lithotriptor V	10	57	0.5%	73.6%
Ultrasonic Probe	4	212	0.5%	91.6%
Boston Scientific	1	5	3.3%	55%

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
Gyrus Acmi	1,064	85.7%
Richard Wolf	14	1.1%
Olympus Medical System	2	0.2%
Olympus Optical	2	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

Death0.3%4

Injury3.5%44

Malfunction95.2%1,181

Other0.8%10

Not given0.2%2

Who filed

Manufacturer report95.6%1,186

Voluntary report1.5%19

User facility report0%0

Distributor report0.7%9

Not given2.2%27

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	257	20.7%
Output problem	119	9.6%
Communication or transmission problemthe device could not communicate or transmit	89	7.2%
Defective devicethe device was defective	65	5.2%
Activation problem	55	4.4%
No device output	49	3.9%
Failure to power up	45	3.6%
Connection problema connection problem	40	3.2%
Power problem	40	3.2%
Energy output problem	38	3.1%
Activation failure	34	2.7%
Defective component	25	2%
Electrical /electronic property probleman electrical or electronic problem	24	1.9%
Degraded	19	1.5%
Crackthe device cracked	17	1.4%
Material twisted/bent	17	1.4%
Material integrity problema problem with the device material	15	1.2%
Loss of powerthe device lost power	14	1.1%
Corrodedthe device corroded	13	1%
Leak/splashthe device leaked	12	1%

Questions about lithotriptor, ultrasonic reports

What is product code FEO?

FDA's classification code for "Lithotriptor, ultrasonic", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,241 reports through August 2026, 378 of them in the latest 12 months.

Which brands appear most often?

Shockpulse Lithotripsy Transducer (467), Shockpulse-Se Lithotripsy System (269), Shockpulse-Se Lithotripsy System Reusab (205), Single Use Mechanical Lithotriptor V (10) and Ultrasonic Probe (4). 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.