Reported Reactions

Devices › Clip, implantable

Device brand name · Clip implantable

Rotating Multiple Clip Applier: medical device reports filed with FDA

1,798 reports name it, 2010–2016. Manufacturer given most often on reports: Ethicon Endo-Surgery. Product code FZP.

1,798
device reports naming the brand
0% of all MAUDE reports · about 115 a year
0
reports, 12 months to August 2026
0 in the 12 months before
94.2%
classified as malfunction
90.6% across the product code
0.2%
classified as death, as reported
3 reports · not verified by FDA

FDA's MAUDE database holds 1,798 reports that name the brand "Rotating Multiple Clip Applier" (clip implantable), received between December 2010 and September 2016; the manufacturer given most often on reports is Ethicon Endo-Surgery. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (94.2%), injury (5.7%) and death (0.2%); across all clip, implantable reports (product code FZP) death is recorded in 0.3% and malfunction in 90.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to form staple (49.3%), component falling (10.6%) and device operates differently than expected (10.5%). The patient problems coded most often are surgical procedure, additional, bleeding and other (for use when an appropriate patient code cannot be identified). 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

No report naming Rotating Multiple Clip Applier was received in the five years to August 2026; the latest was received in September 2016.

By year received

04338662010: 520102011: 47320112012: 5520122013: 9820132014: 86620142015: 8720152016: 2142016

Event type and report source

Event type, as classified on the report

Death0.2%3
Injury5.7%102
Malfunction94.2%1,693
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,798
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 42,395 reports carrying product code FZP. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to form staple88749.3%27.7%
Component falling19110.6%3.8%
Device operates differently than expectedthe device behaved unexpectedly18910.5%4.6%
Misfire1035.7%5.7%
Difficult to open or close884.9%8.1%
Material deformation854.7%2.1%
Failure to fire834.6%8%
Mechanical jam804.4%6.4%
Unintended ejection603.3%1.9%
Mechanical problema mechanical problem422.3%5.9%
Device dislodged or dislocated412.3%0.8%
Mechanics altered341.9%9.4%
Failure to advance311.7%1.3%
Device slipped281.6%1.8%
Sticking281.6%2.7%
Detachment of device component271.5%1.6%
Insufficient device problem information251.4%1.4%
Leak/splashthe device leaked241.3%0.5%
Device inoperablethe device could not be used221.2%0.6%
Failure to align201.1%1.1%

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)ReportsShare
Surgical procedure, additional402.2%
Bleeding321.8%
Other (for use when an appropriate patient code cannot be identified)271.5%
Hospitalization required231.3%
Surgical procedure140.8%
Failure to anastomose130.7%
Surgical procedure, repeated100.6%
Hemorrhage/blood loss/bleeding90.5%
Blood loss80.4%
Leak(s), perivalvular80.4%
No patient involvement80.4%
Dural tear70.4%
Foreign body, removal of50.3%
Surgery, prolonged50.3%
Deaththe patient died; cause not stated by this term40.2%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureRotating Multiple Clip ApplierProduct code FZPAll MAUDE reports
Reports1,79842,39526,136,888
Share of that pool—4.2%0%
Classified as death, per 1,000 reports239
Classified as injury5.7%8%36.2%
Classified as malfunction94.2%90.6%62.3%
Filed by the manufacturer100%96.6%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 FZP

BrandReportsLatest 12 monthsClassified as death
Ligamax-5mm Endo Clip Applier6,8362340%
Auto Endo5 Ml2,069220%
Ligaclip Endo Rotating Mca2,2091090%
Ligaclip Clip Applier1,78700%
Endo Clip1,308850.1%
Ligaclip Endoscopic Clip Applier1,27800%
Ligamax-5mm1,22200.1%
Ca500 Epix Universal Clip Applier 3/Bx1,15400.1%
Ca090 Direct Drive Lca 3/Bx1,14300.2%
Ligaclip1,4253080%
Ligamax1,0293080%
Epix Universal Clip Applier8662320%
Ligaclip Endoscopic Rotating Multiple Clip Applier 20 Large Titanium Ligating Cl85900%
Lapra-Ty Absorbable X6 Suture Clip8281180%
Ligamax Clip Applier73600.1%

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 Rotating Multiple Clip Applier reports

How many FDA reports name Rotating Multiple Clip Applier?

1,798 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (94.2%), injury (5.7%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to form staple (49.3%), component falling (10.6%), device operates differently than expected (10.5%), misfire (5.7%) and difficult to open or close (4.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Rotating Multiple Clip Applier 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.