Lithotriptor, biliary mechanical: medical device reports filed with FDA

2,901 reports carry this product code, 1996–2026; 8 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.

2,901
reports with this product code: 0% of all MAUDE reports; 193
reports, 12 months to August 2026: 132 in the 12 months before; 75.9%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

Product code LQC is FDA's classification for "Lithotriptor, biliary mechanical" (gastroenterology, Urology panel), a class 2 device. 2,901 medical device reports carry this product code, 0% of the MAUDE database, from May 1996 to August 2026.

193 reports arrived in the 12 months to August 2026, up 46% from 132 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 (75.9%), injury (22.9%) and other (0.6%). 8 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
Trapezoid RX	1,503	132	0.3%	80.7%
Single Use Mechanical Lithotriptor V	553	57	0.5%	73.6%
Trapezoid Rx Lithotripter Compatible Basket	212	0	0.5%	69.3%
Trapezoid Rx Lithotripter Compatible Basket Models 1086 1087 1088	181	0	0%	84%
Karl Storz	2	0	2.1%	24.6%
Flexiva	1	0	0%	93.4%
Single Use 3-Lumen Sphincterotome V	1	256	0.2%	95.7%
Zero Tip	1	44	0%	62.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Boston Scientific - Spencer	712	24.5%
Aomori Olympus	388	13.4%
Olympus Medical Systems	64	2.2%
Olympus Medical System	56	1.9%
Olympus Optical	29	1%
Wilson-Cook Medical	2	0.1%
Boston Scientific - Costa Rica	1	0%

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

Death0.4%12

Injury22.9%665

Malfunction75.9%2,202

Other0.6%17

Not given0.2%5

Who filed

Manufacturer report97.1%2,818

Voluntary report1%29

User facility report0%0

Distributor report0.5%15

Not given1.3%39

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,252	43.2%
Material deformation	371	12.8%
Separation failure	224	7.7%
Detachment of device or device componentpart of the device came off	201	6.9%
Material split, cut or torn	186	6.4%
Difficult to removethe device was hard to remove	182	6.3%
Detachment of device component	139	4.8%
Difficult to open or close	139	4.8%
Other (for use when an appropriate device code cannot be identified)	55	1.9%
Premature activation	50	1.7%
Replace	48	1.7%
Component(s), broken	42	1.4%
Torn material	39	1.3%
Device issuea problem with the device	37	1.3%
Tip breakage	37	1.3%
Wire(s), breakage of	34	1.2%
Source, detachment from	33	1.1%
Device, or device fragments remain in patient	30	1%
Device handling problem	28	1%
Entrapment of device	27	0.9%

Questions about lithotriptor, biliary mechanical reports

What is product code LQC?

FDA's classification code for "Lithotriptor, biliary mechanical", 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?

2,901 reports through August 2026, 193 of them in the latest 12 months.

Which brands appear most often?

Trapezoid RX (1,503), Single Use Mechanical Lithotriptor V (553), Trapezoid Rx Lithotripter Compatible Basket (212), Trapezoid Rx Lithotripter Compatible Basket Models 1086 1087 1088 (181) and Karl Storz (2). 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.