Reported Reactions

Devices › Laparoscope, gynecologic (and accessories)

Device brand name · Laparoscope gynecologic and accessories

Cb030 5mmx35cm Epix Lapa Scissor 10/Bx: medical device reports filed with FDA

281 reports name it, 2016–2023. Manufacturer given most often on reports: Applied Medical Resources. Product code HET.

281
device reports naming the brand
0% of all MAUDE reports · about 27 a year
0
reports, 12 months to August 2026
0 in the 12 months before
98.9%
classified as malfunction
95.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 281 reports that name the brand "Cb030 5mmx35cm Epix Lapa Scissor 10/Bx" (laparoscope gynecologic and accessories), received between April 2016 and December 2023; the manufacturer given most often on reports is Applied Medical Resources. 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 (98.9%) and injury (1.1%); across all laparoscope, gynecologic (and accessories) reports (product code HET) death is recorded in 0.1% and malfunction in 95.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to cut (61.6%), dull, blunt (7.8%) and physical resistance (6.4%). The patient problems coded most often are no patient involvement. 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

01733Sep 2021: 6Oct 2021: 3Nov 2021: 7Dec 2021: 192022Jan 2022: 23Feb 2022: 33Mar 2022: 29Apr 2022: 1May 2022: 3Jun 2022: 6Jul 2022: 1Aug 2022: 1Sep 2022: 1Oct 2022: 1Nov 2022: 3Dec 2022: 22023Jan 2023: 1Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 1Jul 2023: 2Aug 2023: 0Sep 2023: 0Oct 2023: 1Nov 2023: 0Dec 2023: 12024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

0521042016: 820162017: 1520172018: 1920182019: 720192020: 1920202021: 10320212022: 10420222023: 62023

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.1%3
Malfunction98.9%278
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%281
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 17,255 reports carrying product code HET. 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 cut17361.6%1.3%
Dull, blunt227.8%0.2%
Physical resistance186.4%0.1%
Difficult to open or close165.7%0.1%
Mechanical jam113.9%0.1%
Circuit failure72.5%0.1%
Material deformation51.8%1%
Device operates differently than expectedthe device behaved unexpectedly41.4%0.2%
Device contaminated during manufacture or shipping31.1%0%
Output problem31.1%2.3%
Arcing20.7%0%
Detachment of device component20.7%0.4%
Mechanical problema mechanical problem20.7%0.5%
No device output20.7%0.3%
Scratched material20.7%2%
Torn material20.7%0.1%
Breakthe device broke10.4%9.2%
Energy output problem10.4%0%
Failure to conduct10.4%0%
Failure to deliver energy10.4%0%

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
No patient involvement124.3%

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

In context

MeasureCb030 5mmx35cm Epix Lapa Scissor 10/BxProduct code HETAll MAUDE reports
Reports28117,25526,136,888
Share of that pool—1.6%0%
Classified as death, per 1,000 reports019
Classified as injury1.1%3.7%36.2%
Classified as malfunction98.9%95.6%62.3%
Filed by the manufacturer100%98.4%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 HET

BrandReportsLatest 12 monthsClassified as death
Gynecare Morcellex Tissue Morcellator2,42400%
Gynecare X-Tract Morcellator1,06200.6%
Gynecare Morcellex Unknown Product25401.6%
Video telescope "EndoEYE", 10 mm, 0, PAL, HD compatible, autoclavable164640%
Video telescope "EndoEYE", 10 mm, 30, PAL, HD compatible, autoclavable9893550%
Visera Elite Video System Center2,6885720%
Prestige Atra Grasper Dbl-Act 5mm25500%
Karl Storz63302.1%
Visera 4k Uhd Camera Control Unit1,8604250%
HD EndoEYE LAPARO-THORACO VIDEOSCOPE356550%
Olympus2,24092.5%
da Vinci1,4834041.2%
Endoeye Flex 3d Deflectable Videoscope1,8257110%
Endopath Xcel786380.5%
Essure74,0724350.2%

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 Cb030 5mmx35cm Epix Lapa Scissor 10/Bx reports

How many FDA reports name Cb030 5mmx35cm Epix Lapa Scissor 10/Bx?

281 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 (98.9%) and injury (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to cut (61.6%), dull, blunt (7.8%), physical resistance (6.4%), difficult to open or close (5.7%) and mechanical jam (3.9%). 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 Cb030 5mmx35cm Epix Lapa Scissor 10/Bx 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.