Devices › Lithotriptor, biliary mechanical
Device brand name · Lithotriptor biliary mechanical
Trapezoid RX: medical device reports filed with FDA
1,504 reports name it, 2005–2026. Manufacturer given most often on reports: Boston Scientific. Product code LQC.
- 1,504
- device reports naming the brand
- 0% of all MAUDE reports · about 70 a year
- 132
- reports, 12 months to August 2026
- 58 in the 12 months before
- 80.7%
- classified as malfunction
- 75.9% across the product code
- 0.3%
- classified as death, as reported
- 4 reports · not verified by FDA
1,504 medical device reports received by FDA name the brand "Trapezoid RX" (lithotriptor biliary mechanical); the manufacturer given most often on reports is Boston Scientific; received from January 2005 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
132 reports arrived in the 12 months to August 2026, up 128% from 58 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 (80.7%), injury (18.9%) and death (0.3%); 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 (49.1%), material deformation (22.7%) and separation failure (14.5%). The patient problems coded most often are foreign body in patient, hemorrhage/blood loss/bleeding and perforation. 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 | 739 | 49.1% | 43.2% |
| Material deformation | 341 | 22.7% | 12.8% |
| Separation failure | 218 | 14.5% | 7.7% |
| Detachment of device or device componentpart of the device came off | 144 | 9.6% | 6.9% |
| Difficult to open or close | 124 | 8.2% | 4.8% |
| Material split, cut or torn | 87 | 5.8% | 6.4% |
| Detachment of device component | 53 | 3.5% | 4.8% |
| Premature activation | 50 | 3.3% | 1.7% |
| Material twisted/bent | 20 | 1.3% | 0.8% |
| Difficult to removethe device was hard to remove | 19 | 1.3% | 6.3% |
| Deformation due to compressive stress | 16 | 1.1% | 0.6% |
| Difficult to advance | 13 | 0.9% | 0.5% |
| Defective devicethe device was defective | 10 | 0.7% | 0.7% |
| Torn material | 10 | 0.7% | 1.3% |
| Mechanical jam | 6 | 0.4% | 0.7% |
| Leak/splashthe device leaked | 5 | 0.3% | 0.7% |
| Tear, rip or hole in device packaging | 4 | 0.3% | 0.1% |
| Device-device incompatibility | 3 | 0.2% | 0.1% |
| Material separation | 3 | 0.2% | 0.7% |
| Mechanical problema mechanical problem | 3 | 0.2% | 0.9% |
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 | 13 | 0.9% |
| Hemorrhage/blood loss/bleeding | 13 | 0.9% |
| Perforation | 8 | 0.5% |
| Inflammationinflammation | 5 | 0.3% |
| No patient involvement | 5 | 0.3% |
| Painpain, site not specified | 4 | 0.3% |
| Deaththe patient died; cause not stated by this term | 3 | 0.2% |
| Device embedded in tissue or plaque | 2 | 0.1% |
| Fever | 2 | 0.1% |
| Swelling/ edema | 2 | 0.1% |
| Abdominal painstomach or belly pain | 1 | 0.1% |
| Anxietyanxiety | 1 | 0.1% |
| Biliary leak | 1 | 0.1% |
| Bradycardiaslow heart rate | 1 | 0.1% |
| Bruise/contusion | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Trapezoid RX | Product code LQC | All MAUDE reports |
|---|---|---|---|
| Reports | 1,504 | 2,901 | 26,136,888 |
| Share of that pool | — | 51.8% | 0% |
| Classified as death, per 1,000 reports | 3 | 4 | 9 |
| Classified as injury | 18.9% | 22.9% | 36.2% |
| Classified as malfunction | 80.7% | 75.9% | 62.3% |
| Filed by the manufacturer | 98.9% | 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 |
|---|---|---|---|
| Single Use Mechanical Lithotriptor V | 564 | 57 | 0.5% |
| 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 Trapezoid RX reports
How many FDA reports name Trapezoid RX?
1,504 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 132 in the latest 12 months.
What kinds of events are reported?
malfunction (80.7%), injury (18.9%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (49.1%), material deformation (22.7%), separation failure (14.5%), detachment of device or device component (9.6%) and difficult to open or close (8.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Trapezoid RX 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.