Hemostatic metal clip for the gi tract: medical device reports filed with FDA

7,243 reports carry this product code, 2012–2026; 12 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.

7,243
reports with this product code: 0% of all MAUDE reports; 966
reports, 12 months to August 2026: 1,358 in the 12 months before; 90.9%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code PKL is FDA's classification for "Hemostatic metal clip for the gi tract" (gastroenterology, Urology panel), a class 2 device. 7,243 medical device reports carry this product code, 0% of the MAUDE database, from May 2012 to August 2026.

966 reports arrived in the 12 months to August 2026, down 29% from 1,358 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 (90.9%), injury (8.7%) and death (0.3%). 12 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
Resolution 360 Clip	2,956	385	0.2%	95.9%
Instinct Plus Endoscopic Clipping Device	1,225	229	0%	97.1%
Resolution Clip	696	36	0.1%	98.3%
Resolution 360 ULTRA Clip	608	116	1%	96.2%
Instinct Endoscopic Hemoclip	350	0	0.1%	87.8%
Single Use Repositionable Clip	275	0	0%	67.3%
Mantis	173	33	0.6%	88.4%
Resolution Clip Clipping Device	131	28	0.1%	93.7%
Instinct	51	1,171	0%	91.7%
6 Shooter Saeed Multi-Band Ligator	1	92	0.1%	89.4%
Boston Scientific	1	5	3.3%	55%
Hemospray Endoscopic Hemostat	1	116	0.9%	83.6%

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
Wilson-Cook Medical	1,071	14.8%
Boston Scientific - Marlborough	555	7.7%
Cook Endoscopy	517	7.1%
Aomori Olympus	307	4.2%
Olympus Medical Systems	110	1.5%
Apollo Endosurgery	31	0.4%
Boston Scientific	17	0.2%
Olympus Medical System	3	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

Death0.3%25

Injury8.7%628

Malfunction90.9%6,587

Other0%1

Not given0%2

Who filed

Manufacturer report93.9%6,801

Voluntary report2.2%161

User facility report0%0

Distributor report0.3%21

Not given3.6%260

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

Device problems coded

Device problem (FDA code)	Reports	Share
Activation, positioning or separation problem	3,824	52.8%
Difficult to open or close	982	13.6%
Material separation	676	9.3%
Premature activation	517	7.1%
Failure to fire	428	5.9%
Breakthe device broke	421	5.8%
Separation failure	382	5.3%
Premature separation	323	4.5%
Detachment of device or device componentpart of the device came off	206	2.8%
Human-device interface problem	125	1.7%
Positioning failure	123	1.7%
Material deformation	119	1.6%
Improper or incorrect procedure or method	113	1.6%
Entrapment of device	111	1.5%
Material twisted/bent	103	1.4%
Difficult or delayed separation	64	0.9%
Failure to advance	64	0.9%
Difficult to removethe device was hard to remove	44	0.6%
Activation failure	39	0.5%
Device fell	39	0.5%

Questions about hemostatic metal clip for the gi tract reports

What is product code PKL?

FDA's classification code for "Hemostatic metal clip for the gi tract", 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?

7,243 reports through August 2026, 966 of them in the latest 12 months.

Which brands appear most often?

Resolution 360 Clip (2,956), Instinct Plus Endoscopic Clipping Device (1,225), Resolution Clip (696), Resolution 360 ULTRA Clip (608) and Instinct Endoscopic Hemoclip (350). 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.