Devices › Lithotriptor, biliary mechanical
Device brand name · Single use mechanical lithotriptor
Single Use Mechanical Lithotriptor V: medical device reports filed with FDA
564 reports name it, 2012–2026. Manufacturer given most often on reports: Aomori Olympus. Product code LQC.
- 564
- device reports naming the brand
- 0% of all MAUDE reports · about 40 a year
- 57
- reports, 12 months to August 2026
- 66 in the 12 months before
- 73.6%
- classified as malfunction
- 75.9% across the product code
- 0.5%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 564 reports that name the brand "Single Use Mechanical Lithotriptor V" (single use mechanical lithotriptor), received between June 2012 and August 2026; the manufacturer given most often on reports is Aomori Olympus. Spellings of one product vary from report to report.
57 reports arrived in the 12 months to August 2026, down 14% from 66 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 (73.6%), injury (25.7%) and death (0.5%); across all lithotriptor, biliary mechanical reports (product code LQC) death is recorded in 0.4% and malfunction in 75.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (52.3%), material split, cut or torn (17.4%) and difficult to remove (8.5%). The patient problems coded most often are foreign body in patient, device embedded in tissue or plaque and pancreatitis. 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
Who filed the report
Grey bar: all 2,901 reports carrying product code LQC. 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 | 295 | 52.3% | 43.2% |
| Material split, cut or torn | 98 | 17.4% | 6.4% |
| Difficult to removethe device was hard to remove | 48 | 8.5% | 6.3% |
| Detachment of device or device componentpart of the device came off | 47 | 8.3% | 6.9% |
| Entrapment of device | 16 | 2.8% | 0.9% |
| Crackthe device cracked | 11 | 2% | 0.4% |
| Material deformation | 11 | 2% | 12.8% |
| Mechanical problema mechanical problem | 11 | 2% | 0.9% |
| Device handling problem | 6 | 1.1% | 1% |
| Material separation | 6 | 1.1% | 0.7% |
| Mechanical jam | 6 | 1.1% | 0.7% |
| Retraction problem | 5 | 0.9% | 0.4% |
| Difficult to open or close | 4 | 0.7% | 4.8% |
| Physical resistance/sticking | 4 | 0.7% | 0% |
| Defective component | 3 | 0.5% | 0.1% |
| Detachment of device component | 3 | 0.5% | 4.8% |
| Material integrity problema problem with the device material | 3 | 0.5% | 0.1% |
| Defective devicethe device was defective | 2 | 0.4% | 0.7% |
| Device damaged prior to usethe device was damaged before use | 2 | 0.4% | 0.3% |
| Fracturea broken bone | 2 | 0.4% | 0.6% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 27 | 4.8% |
| Device embedded in tissue or plaque | 19 | 3.4% |
| Pancreatitisinflammation of the pancreas | 11 | 2% |
| Perforation | 9 | 1.6% |
| Hemorrhage/blood loss/bleeding | 7 | 1.2% |
| Pneumonialung infection | 6 | 1.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 0.9% |
| Injurya physical injury | 5 | 0.9% |
| Abdominal painstomach or belly pain | 4 | 0.7% |
| Cardiac arrestthe heart stopped | 4 | 0.7% |
| Cholangitis | 4 | 0.7% |
| Septic shockshock arising from infection | 4 | 0.7% |
| Hypoxialow oxygen | 2 | 0.4% |
| Bowel perforation | 1 | 0.2% |
| Fever | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Single Use Mechanical Lithotriptor V | Product code LQC | All MAUDE reports |
|---|---|---|---|
| Reports | 564 | 2,901 | 26,136,888 |
| Share of that pool | — | 19.4% | 0% |
| Classified as death, per 1,000 reports | 5 | 4 | 9 |
| Classified as injury | 25.7% | 22.9% | 36.2% |
| Classified as malfunction | 73.6% | 75.9% | 62.3% |
| Filed by the manufacturer | 98.4% | 97.1% | 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 LQC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Trapezoid RX | 1,504 | 132 | 0.3% |
| Trapezoid Rx Lithotripter Compatible Basket | 212 | 0 | 0.5% |
| Trapezoid Rx Lithotripter Compatible Basket Models 1086 1087 1088 | 181 | 0 | 0% |
| Karl Storz | 633 | 0 | 2.1% |
| Flexiva | 229 | 0 | 0% |
| Single Use 3-Lumen Sphincterotome V | 1,767 | 256 | 0.2% |
| Zero Tip | 485 | 44 | 0% |
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 Single Use Mechanical Lithotriptor V reports
How many FDA reports name Single Use Mechanical Lithotriptor V?
564 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 57 in the latest 12 months.
What kinds of events are reported?
malfunction (73.6%), injury (25.7%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (52.3%), material split, cut or torn (17.4%), difficult to remove (8.5%), detachment of device or device component (8.3%) and entrapment of device (2.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.4%) and distributor reports (1.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Single Use Mechanical Lithotriptor V 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.