Devices › Dislodger, stone, basket, ureteral, metal
Device brand name · Dislodger stone basket ureteral metal
Zero Tip: medical device reports filed with FDA
485 reports name it, 2011–2026. Manufacturer given most often on reports: Boston Scientific. Product code FFL.
- 485
- device reports naming the brand
- 0% of all MAUDE reports · about 33 a year
- 44
- reports, 12 months to August 2026
- 65 in the 12 months before
- 62.3%
- classified as malfunction
- 82.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 485 reports that name the brand "Zero Tip" (dislodger stone basket ureteral metal), received between September 2011 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
44 reports arrived in the 12 months to August 2026, down 32% from 65 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 (62.3%) and injury (37.7%); across all dislodger, stone, basket, ureteral, metal reports (product code FFL) death is recorded in 0.1% and malfunction in 82.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (34.8%), detachment of device or device component (23.3%) and difficult to open or close (12%). The patient problems coded most often are urinary tract infection, foreign body in patient and no patient involvement. 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 6,121 reports carrying product code FFL. 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 | 169 | 34.8% | 28.6% |
| Detachment of device or device componentpart of the device came off | 113 | 23.3% | 5.7% |
| Difficult to open or close | 58 | 12% | 32.4% |
| Detachment of device component | 43 | 8.9% | 4.4% |
| Material split, cut or torn | 23 | 4.7% | 2.4% |
| Tear, rip or hole in device packaging | 14 | 2.9% | 0.7% |
| Material deformation | 12 | 2.5% | 3.1% |
| Unsealed device packaging | 11 | 2.3% | 0.4% |
| Device contamination with chemical or other material | 10 | 2.1% | 0.9% |
| Nonstandard device | 10 | 2.1% | 0.4% |
| Device contaminated during manufacture or shipping | 9 | 1.9% | 0.7% |
| Device packaging compromised | 8 | 1.6% | 0.2% |
| Entrapment of device | 4 | 0.8% | 0.4% |
| Defective devicethe device was defective | 3 | 0.6% | 0.5% |
| Deformation due to compressive stress | 3 | 0.6% | 1% |
| Material twisted/bent | 3 | 0.6% | 1.5% |
| Device-device incompatibility | 2 | 0.4% | 0% |
| Physical resistance/sticking | 2 | 0.4% | 0.2% |
| Torn material | 2 | 0.4% | 0.1% |
| Component missing | 1 | 0.2% | 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 |
|---|---|---|
| Urinary tract infectionbladder or urinary infection | 19 | 3.9% |
| Foreign body in patientpart of a device left in the patient | 17 | 3.5% |
| No patient involvement | 13 | 2.7% |
| Device embedded in tissue or plaque | 9 | 1.9% |
| Sepsisa severe body-wide response to infection | 9 | 1.9% |
| Hemorrhage/blood loss/bleeding | 8 | 1.6% |
| Hematuria | 7 | 1.4% |
| Fever | 5 | 1% |
| Perforation | 5 | 1% |
| Inflammationinflammation | 4 | 0.8% |
| Laceration(s) | 3 | 0.6% |
| Painpain, site not specified | 3 | 0.6% |
| Renal failurekidney failure | 3 | 0.6% |
| Abscessa collection of pus | 2 | 0.4% |
| Biliary leak | 2 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Zero Tip | Product code FFL | All MAUDE reports |
|---|---|---|---|
| Reports | 485 | 6,121 | 26,136,888 |
| Share of that pool | — | 7.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 37.7% | 16.4% | 36.2% |
| Classified as malfunction | 62.3% | 82.7% | 62.3% |
| Filed by the manufacturer | 94.2% | 93.8% | 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 FFL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| NCircle Tipless Stone Extractor | 1,463 | 232 | 0% |
| Ngage Nitinol Stone Extractor | 1,193 | 1 | 0% |
| Ncircle Delta Wire Tipless Stone Extractor | 281 | 28 | 0% |
| Ncompass Nitinol Tipless Stone Extractor | 172 | 14 | 0% |
| Zero Tip Nitinol Stone Retrieval Basket | 173 | 0 | 0% |
| Gemini | 172 | 11 | 0.6% |
| Boston Scientific | 580 | 5 | 3.3% |
| Karl Storz | 633 | 0 | 2.1% |
| Cook | 271 | 6 | 2.2% |
| Olympus | 2,240 | 9 | 2.5% |
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 Zero Tip reports
How many FDA reports name Zero Tip?
485 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 44 in the latest 12 months.
What kinds of events are reported?
malfunction (62.3%) and injury (37.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (34.8%), detachment of device or device component (23.3%), difficult to open or close (12%), detachment of device component (8.9%) and material split, cut or torn (4.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (94.2%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Zero Tip 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.