Laparoscope, gynecologic (and accessories): medical device reports filed with FDA

17,255 reports carry this product code, 1993–2026; 17 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.

17,255
reports with this product code: 0.1% of all MAUDE reports; 5,067
reports, 12 months to August 2026: 4,256 in the 12 months before; 95.6%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code HET is FDA's classification for "Laparoscope, gynecologic (and accessories)" (obstetrics/Gynecology panel), a class 2 device. 17,255 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1993 to August 2026.

5,067 reports arrived in the 12 months to August 2026, up 19% from 4,256 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 (95.6%), injury (3.7%) and other (0.4%). 17 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
Gynecare Morcellex Tissue Morcellator	2,401	0	0%	95.1%
Gynecare X-Tract Morcellator	1,027	0	0.6%	93.1%
Cb030 5mmx35cm Epix Lapa Scissor 10/Bx	279	0	0%	98.9%
Gynecare Morcellex Unknown Product	232	0	1.6%	0.4%
Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable	17	64	0%	100%
Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable	17	355	0%	99.9%
Visera Elite Video System Center	7	572	0%	99.6%
Prestige Atra Grasper Dbl-Act 5mm	6	0	0%	79.6%
Karl Storz	3	0	2.1%	24.6%
Visera 4k Uhd Camera Control Unit	3	425	0%	99.5%
HD EndoEYE LAPARO-THORACO VIDEOSCOPE	2	55	0%	99.4%
Olympus	2	9	2.5%	69.7%
da Vinci	1	404	1.2%	27.2%
Endoeye Flex 3d Deflectable Videoscope	1	711	0%	98.2%
Endopath Xcel	1	38	0.5%	95.2%
Essure	1	435	0.2%	1.4%
Visera 4k Uhd Xenon Light Source	1	101	0%	97.9%

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
Olympus Winter & Ibe	12,230	70.9%
Ethicon	3,751	21.7%
Applied Medical Resources	388	2.2%
Applied Medical	32	0.2%
Ethicon Endo-Surgery	30	0.2%
Covidien Formerly Ussc Puerto Rico	29	0.2%
Ussc Puerto Rico	26	0.2%
Ethicon Endo-Surgery De C V	13	0.1%
Conmed	11	0.1%
Coopersurgical	11	0.1%
Richard Wolf	8	0%
Davol Sub C R Bard -1213643	7	0%
Davol Sub C R Bard	5	0%
Stryker Endoscopy	3	0%
Davol	2	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%24

Injury3.7%639

Malfunction95.6%16,501

Other0.4%65

Not given0.2%26

Who filed

Manufacturer report98.4%16,982

Voluntary report0.6%101

User facility report0%0

Distributor report0.2%38

Not given0.8%134

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

Device problems coded

Device problem (FDA code)	Reports	Share
Poor quality image	5,021	29.1%
Other (for use when an appropriate device code cannot be identified)	3,585	20.8%
Breakthe device broke	1,592	9.2%
No display/image	1,496	8.7%
Communication or transmission problemthe device could not communicate or transmit	1,171	6.8%
Dent in material	723	4.2%
Erratic or intermittent display	560	3.2%
Optical discoloration	473	2.7%
Output problem	397	2.3%
Material split, cut or torn	379	2.2%
Fracturea broken bone	365	2.1%
Scratched material	341	2%
Crackthe device cracked	328	1.9%
Leak/splashthe device leaked	291	1.7%
Loose or intermittent connection	288	1.7%
Optical problem	274	1.6%
Material twisted/bent	244	1.4%
Image display error/artifact	242	1.4%
Display or visual feedback problem	231	1.3%
Failure to cut	217	1.3%

Questions about laparoscope, gynecologic (and accessories) reports

What is product code HET?

FDA's classification code for "Laparoscope, gynecologic (and accessories)", class 2, reviewed by the obstetrics/Gynecology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

17,255 reports through August 2026, 5,067 of them in the latest 12 months.

Which brands appear most often?

Gynecare Morcellex Tissue Morcellator (2,401), Gynecare X-Tract Morcellator (1,027), Cb030 5mmx35cm Epix Lapa Scissor 10/Bx (279), Gynecare Morcellex Unknown Product (232) and Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable (17). 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.