Devices › Laparoscope, general & plastic surgery
Device brand name · Endo linear cutters - ets45mm
Endopath Ets Flex45 Endoscopic Articulating Linear: medical device reports filed with FDA
769 reports name it, 2003–2006. Manufacturer given most often on reports: Ethicon Endo-Surgery Cincinnati. Product code GCJ.
- 769
- device reports naming the brand
- 0% of all MAUDE reports · about 33 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 80.2%
- classified as malfunction
- 90.1% across the product code
- 0.5%
- classified as death, as reported
- 4 reports · not verified by FDA
769 medical device reports received by FDA name the brand "Endopath Ets Flex45 Endoscopic Articulating Linear" (endo linear cutters - ets45mm); the manufacturer given most often on reports is Ethicon Endo-Surgery Cincinnati; received from February 2003 to September 2006. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (80.2%), injury (19%) and death (0.5%); across all laparoscope, general & plastic surgery reports (product code GCJ) death is recorded in 0.3% and malfunction in 90.1%. 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 (52.8%), replace (49.3%) and sticking (16.4%). The patient problems coded most often are failure to anastomose, surgical procedure aborted/stopped and surgical procedure, additional. 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 Endopath Ets Flex45 Endoscopic Articulating Linear was received in the five years to August 2026; the latest was received in September 2006.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 84,093 reports carrying product code GCJ. 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 |
|---|---|---|---|
| Failure to form staple | 406 | 52.8% | 3.3% |
| Replace | 379 | 49.3% | 12.3% |
| Sticking | 126 | 16.4% | 3% |
| Failure to cut | 90 | 11.7% | 0.6% |
| Failure to fire | 66 | 8.6% | 1.9% |
| Device issuea problem with the device | 39 | 5.1% | 7.1% |
| Misfire | 29 | 3.8% | 1.5% |
| Noise | 21 | 2.7% | 0.1% |
| Lockout mechanism failure | 14 | 1.8% | 0.1% |
| Other (for use when an appropriate device code cannot be identified) | 12 | 1.6% | 0.6% |
| Component missing | 11 | 1.4% | 0.6% |
| Detachment of device component | 9 | 1.2% | 5.3% |
| Device, removal of (non-implant) | 9 | 1.2% | 0.8% |
| Locking mechanism failure | 9 | 1.2% | 0.1% |
| Breakthe device broke | 8 | 1% | 13.5% |
| Component falling | 8 | 1% | 1.6% |
| Close, difficult to | 7 | 0.9% | 0.2% |
| Leak/splashthe device leaked | 7 | 0.9% | 3.9% |
| Clips, scissored | 6 | 0.8% | 0.1% |
| Component(s), broken | 5 | 0.7% | 2.5% |
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 |
|---|---|---|
| Failure to anastomose | 263 | 34.2% |
| Surgical procedure aborted/stopped | 93 | 12.1% |
| Surgical procedure, additional | 72 | 9.4% |
| Bleeding | 61 | 7.9% |
| Surgery, prolonged | 57 | 7.4% |
| Surgical procedure | 45 | 5.9% |
| Therapy/non-surgical treatment, additional | 34 | 4.4% |
| Transfusion of blood products | 26 | 3.4% |
| Blood loss | 17 | 2.2% |
| Foreign body, removal of | 12 | 1.6% |
| Therapy/non-surgical treatment/delayed/prolonged | 6 | 0.8% |
| Deaththe patient died; cause not stated by this term | 5 | 0.7% |
| Dural tear | 5 | 0.7% |
| Laparotomy | 4 | 0.5% |
| Hemorrhage/blood loss/bleeding | 3 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endopath Ets Flex45 Endoscopic Articulating Linear | Product code GCJ | All MAUDE reports |
|---|---|---|---|
| Reports | 769 | 84,093 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 5 | 3 | 9 |
| Classified as injury | 19% | 8.3% | 36.2% |
| Classified as malfunction | 80.2% | 90.1% | 62.3% |
| Filed by the manufacturer | 100% | 94.8% | 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 GCJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endoeye Flex Deflectable Videoscope | 8,062 | 2,245 | 0% |
| Auto Suture | 3,100 | 234 | 0.1% |
| Endopath Dilating Tip Trocar | 2,475 | 0 | 0.4% |
| VersaOne | 1,890 | 251 | 0.2% |
| Endoeye Flex 3d Deflectable Videoscope | 1,825 | 711 | 0% |
| Spacemaker | 1,379 | 146 | 0% |
| Versaport | 1,198 | 64 | 0.1% |
| Endopath Disposable Surgical Trocar | 1,153 | 0 | 0.4% |
| Pdb | 1,253 | 180 | 0% |
| Endopath Xcel Bladeless Trocar | 986 | 28 | 0.3% |
| Auto Suture Multifire Endo Gia 30-2 5 | 933 | 0 | 0% |
| Endopath Xcel Trocar | 844 | 0 | 0.9% |
| Lapro-Clip | 856 | 54 | 0.2% |
| Auto Suture Endo Clip 5mm | 795 | 0 | 0% |
| Endopath Xcel | 786 | 38 | 0.5% |
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 Endopath Ets Flex45 Endoscopic Articulating Linear reports
How many FDA reports name Endopath Ets Flex45 Endoscopic Articulating Linear?
769 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 (80.2%), injury (19%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to form staple (52.8%), replace (49.3%), sticking (16.4%), failure to cut (11.7%) and failure to fire (8.6%). 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 Endopath Ets Flex45 Endoscopic Articulating Linear 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.