Laparoscope, general & plastic surgery: medical device reports filed with FDA

84,093 reports carry this product code, 1992–2026; 30 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.

84,093
reports with this product code: 0.3% of all MAUDE reports; 7,022
reports, 12 months to August 2026: 5,541 in the 12 months before; 90.1%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code GCJ is FDA's classification for "Laparoscope, general & plastic surgery" (gastroenterology, Urology panel), a class 2 device. 84,093 medical device reports carry this product code, 0.3% of the MAUDE database, from July 1992 to August 2026.

7,022 reports arrived in the 12 months to August 2026, up 27% from 5,541 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 (90.1%), injury (8.3%) and other (0.6%). 30 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
Endoeye Flex Deflectable Videoscope	8,053	2,245	0%	99.5%
Auto Suture	2,829	234	0.1%	94.6%
Endopath Dilating Tip Trocar	2,473	0	0.4%	93.8%
VersaOne	1,890	251	0.2%	94.2%
Endoeye Flex 3d Deflectable Videoscope	1,824	711	0%	98.2%
Spacemaker	1,377	146	0%	97%
Versaport	1,198	64	0.1%	95.8%
Endopath Disposable Surgical Trocar	1,151	0	0.4%	95.1%
Pdb	1,134	180	0%	99%
Endopath Xcel Bladeless Trocar	986	28	0.3%	96.2%
Auto Suture Multifire Endo Gia 30-2 5	926	0	0%	94.5%
Endopath Xcel Trocar	843	0	0.9%	96.3%
Lapro-Clip	835	54	0.2%	89.1%
Auto Suture Endo Clip 5mm	793	0	0%	98.5%
Endopath Xcel	778	38	0.5%	95.2%
Protack	754	44	0.1%	90%
Auto Suture Multifire Endo Gia 30-3 5	749	0	0%	85.3%
Proximate Thick Tissue Linear Cutter	718	0	0.6%	97.1%
4k Uhd Lcd Monitor	711	305	0%	99.7%
Endopouch Retriever Spec Bag	667	35	0%	95%
Endopath Ets Flex45 Endoscopic Articulating Linear	664	0	0.5%	80.2%
Spacemaker Blunt Tip Trocar 10mm	588	0	0%	95.1%
Lap Disc Hand Access Device	568	0	0%	96.1%
Spacemaker Preperitoneal Dist Balloon	522	0	0%	95.8%
Spacemaker Blunt Tip Trocar 12mm	454	0	0%	94.1%
Endopath Xcel Bladeless Trocar With Stability Sleeve	430	0	0.2%	98.6%
Spacemaker Plus	413	0	0%	98.1%
Endopath Articulating Linear Cutter	387	0	1%	83%
Terumo Virtuosaph Vein Harvesting System	374	0	0%	72.5%
Camera Head	370	948	0%	99.9%

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
Ethicon Endo-Surgery	12,341	14.7%
United States Surgical	10,352	12.3%
Aizu Olympus	8,224	9.8%
US Surgical Puerto Rico	6,729	8%
Davis & Geck Caribe	3,901	4.6%
Applied Medical Resources	3,638	4.3%
Olympus Medical Systems	2,430	2.9%
Intuitive Surgical	2,194	2.6%
Stryker Endoscopy-San Jose	2,157	2.6%
Ethicon Endo-Surgery De C V	2,125	2.5%
Ethicon Endo-Surgery Cincinnati	1,984	2.4%
Covidien	1,964	2.3%
Ponce - Uss	1,624	1.9%
Shirakawa Olympus	1,482	1.8%
Covidien Formerly Ussc Puerto Rico	1,395	1.7%

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%262

Injury8.3%6,956

Malfunction90.1%75,731

Other0.6%503

Not given0.8%641

Who filed

Manufacturer report94.8%79,682

Voluntary report2%1,668

User facility report0%0

Distributor report0.4%377

Not given2.8%2,366

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	11,313	13.5%
Replace	10,356	12.3%
Device issuea problem with the device	5,986	7.1%
No display/image	5,504	6.5%
Detachment of device or device componentpart of the device came off	5,082	6%
Detachment of device component	4,474	5.3%
Inflation problem	3,605	4.3%
Leak/splashthe device leaked	3,318	3.9%
Poor quality image	2,974	3.5%
Tears, rips, holes in device, device material	2,821	3.4%
Failure to form staple	2,788	3.3%
Sticking	2,499	3%
Component(s), broken	2,121	2.5%
Material split, cut or torn	2,104	2.5%
Material fragmentation	2,001	2.4%
Air leak	1,858	2.2%
Communication or transmission problemthe device could not communicate or transmit	1,738	2.1%
Peeled/delaminated	1,581	1.9%
Failure to fire	1,558	1.9%
Gas/air leak	1,417	1.7%

Questions about laparoscope, general & plastic surgery reports

What is product code GCJ?

FDA's classification code for "Laparoscope, general & plastic surgery", 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?

84,093 reports through August 2026, 7,022 of them in the latest 12 months.

Which brands appear most often?

Endoeye Flex Deflectable Videoscope (8,053), Auto Suture (2,829), Endopath Dilating Tip Trocar (2,473), VersaOne (1,890) and Endoeye Flex 3d Deflectable Videoscope (1,824). 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.