Dislodger, stone, basket, ureteral, metal: medical device reports filed with FDA

6,121 reports carry this product code, 1992–2026; 11 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.

6,121
reports with this product code: 0% of all MAUDE reports; 430
reports, 12 months to August 2026: 536 in the 12 months before; 82.7%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code FFL is FDA's classification for "Dislodger, stone, basket, ureteral, metal" (gastroenterology, Urology panel), a class 2 device. 6,121 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

430 reports arrived in the 12 months to August 2026, down 20% from 536 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 (82.7%), injury (16.4%) and other (0.4%). 11 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
NCircle Tipless Stone Extractor	1,457	232	0%	93%
Ngage Nitinol Stone Extractor	1,192	1	0%	98.9%
Zero Tip	472	44	0%	62.3%
Ncircle Delta Wire Tipless Stone Extractor	281	28	0%	98.2%
Ncompass Nitinol Tipless Stone Extractor	172	14	0%	99.4%
Zero Tip Nitinol Stone Retrieval Basket	172	0	0%	79.8%
Gemini	134	11	0.6%	70.9%
Boston Scientific	2	5	3.3%	55%
Karl Storz	2	0	2.1%	24.6%
Cook	1	6	2.2%	45%
Olympus	1	9	2.5%	69.7%

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
Cook	3,305	54%
Boston Scientific - Spencer	556	9.1%
Wilson-Cook Medical	211	3.4%
Cook Endoscopy	180	2.9%
Boston Scientific	81	1.3%
C R Bard	25	0.4%
C R Bard Covington -1018233	8	0.1%
C R Bard Covington	7	0.1%
Coloplast A/S	5	0.1%
Bard	2	0%
Applied Medical Resources	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

Death0.1%5

Injury16.4%1,004

Malfunction82.7%5,065

Other0.4%25

Not given0.4%22

Who filed

Manufacturer report93.8%5,739

Voluntary report2.5%150

User facility report0%0

Distributor report0.4%23

Not given3.4%209

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

Device problems coded

Device problem (FDA code)	Reports	Share
Difficult to open or close	1,982	32.4%
Breakthe device broke	1,753	28.6%
Detachment of device or device componentpart of the device came off	347	5.7%
Material separation	295	4.8%
Detachment of device component	272	4.4%
Difficult to removethe device was hard to remove	191	3.1%
Material deformation	190	3.1%
Fracturea broken bone	187	3.1%
Loss of or failure to bond	177	2.9%
Material split, cut or torn	148	2.4%
Device operates differently than expectedthe device behaved unexpectedly	122	2%
Wire(s), breakage of	98	1.6%
Material twisted/bent	91	1.5%
Replace	83	1.4%
Device, removal of (non-implant)	80	1.3%
Device damaged prior to usethe device was damaged before use	79	1.3%
Close, difficult to	70	1.1%
Sticking	65	1.1%
Deformation due to compressive stress	64	1%
Device issuea problem with the device	60	1%

Questions about dislodger, stone, basket, ureteral, metal reports

What is product code FFL?

FDA's classification code for "Dislodger, stone, basket, ureteral, metal", 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?

6,121 reports through August 2026, 430 of them in the latest 12 months.

Which brands appear most often?

NCircle Tipless Stone Extractor (1,457), Ngage Nitinol Stone Extractor (1,192), Zero Tip (472), Ncircle Delta Wire Tipless Stone Extractor (281) and Ncompass Nitinol Tipless Stone Extractor (172). 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.