Device brand name · Lithotriptor ultrasonic

Shockpulse-Se Lithotripsy System: medical device reports filed with FDA

269 reports name it, 2020–2026. Manufacturer given most often on reports: Gyrus Acmi. Product code FEO.

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.

269
device reports naming the brand: 0% of all MAUDE reports · about 44 a year; 89
reports, 12 months to August 2026: 77 in the 12 months before; 97.4%
classified as malfunction: 95.2% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 269 reports that name the brand "Shockpulse-Se Lithotripsy System" (lithotriptor ultrasonic), received between June 2020 and August 2026; the manufacturer given most often on reports is Gyrus Acmi. Spellings of one product vary from report to report.

89 reports arrived in the 12 months to August 2026, up 16% from 77 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 (97.4%) and injury (2.6%); across all lithotriptor, ultrasonic reports (product code FEO) death is recorded in 0.3% and malfunction in 95.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (17.1%), output problem (14.5%) and communication or transmission problem (10%). The patient problems coded most often are no patient involvement, fistula and hemorrhage/blood loss/bleeding. 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

Death0%0

Injury2.6%7

Malfunction97.4%262

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%269

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 1,241 reports carrying product code FEO. 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	46	17.1%	20.7%
Output problem	39	14.5%	9.6%
Communication or transmission problemthe device could not communicate or transmit	27	10%	7.2%
Defective devicethe device was defective	18	6.7%	5.2%
Connection problema connection problem	12	4.5%	3.2%
Material twisted/bent	12	4.5%	1.4%
No device output	11	4.1%	3.9%
Power problem	11	4.1%	3.2%
Energy output problem	10	3.7%	3.1%
Activation problem	9	3.3%	4.4%
Defective component	8	3%	2%
Failure to power up	7	2.6%	3.6%
Crackthe device cracked	6	2.2%	1.4%
Electrical /electronic property probleman electrical or electronic problem	6	2.2%	1.9%
Degraded	3	1.1%	1.5%
Device damaged prior to usethe device was damaged before use	3	1.1%	0.3%
Intermittent loss of power	3	1.1%	0.3%
Protective measures problem	3	1.1%	0.5%
Activation failure	2	0.7%	2.7%
Activation, positioning or separation problem	2	0.7%	0.3%

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	39	14.5%
Fistula	1	0.4%
Hemorrhage/blood loss/bleeding	1	0.4%
Pneumothoraxa collapsed lung	1	0.4%
Sepsisa severe body-wide response to infection	1	0.4%

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

In context

Measure	Shockpulse-Se Lithotripsy System	Product code FEO	All MAUDE reports
Reports	269	1,241	26,136,888
Share of that pool	—	21.7%	0%
Classified as death, per 1,000 reports	0	3	9
Classified as injury	2.6%	3.5%	36.2%
Classified as malfunction	97.4%	95.2%	62.3%
Filed by the manufacturer	100%	95.6%	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 FEO

Brand	Reports	Latest 12 months	Classified as death
Shockpulse Lithotripsy Transducer	467	169	0%
Shockpulse-Se Lithotripsy System Reusab	205	73	0%
Single Use Mechanical Lithotriptor V	564	57	0.5%
Ultrasonic Probe	787	212	0.5%
Boston Scientific	580	5	3.3%

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 Shockpulse-Se Lithotripsy System reports

How many FDA reports name Shockpulse-Se Lithotripsy System?

269 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 89 in the latest 12 months.

What kinds of events are reported?

malfunction (97.4%) and injury (2.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (17.1%), output problem (14.5%), communication or transmission problem (10%), defective device (6.7%) and connection problem (4.5%). 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 Shockpulse-Se Lithotripsy System 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.