Reported Reactions

Devices › Electrosurgical, cutting & coagulation & accessories

Device brand name · Electrosurgical cutting & coagulation & accessories

HemoPro2 Extension Cable: medical device reports filed with FDA

539 reports name it, 2011–2026. Manufacturer given most often on reports: Maquet Cardiovascular. Product code GEI.

539
device reports naming the brand
0% of all MAUDE reports · about 35 a year
30
reports, 12 months to August 2026
34 in the 12 months before
98.5%
classified as malfunction
80.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 539 reports that name the brand "HemoPro2 Extension Cable" (electrosurgical cutting & coagulation & accessories), received between April 2011 and August 2026; the manufacturer given most often on reports is Maquet Cardiovascular. Spellings of one product vary from report to report.

30 reports arrived in the 12 months to August 2026, down 12% from 34 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 (98.5%) and injury (1.5%); across all electrosurgical, cutting & coagulation & accessories reports (product code GEI) death is recorded in 0.4% and malfunction in 80.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (32.3%), failure to deliver energy (21%) and electrical /electronic property problem (7.2%). The patient problems coded most often are no patient involvement, electric shock and surgical procedure. 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

0713Sep 2021: 3Oct 2021: 4Nov 2021: 3Dec 2021: 22022Jan 2022: 0Feb 2022: 0Mar 2022: 5Apr 2022: 1May 2022: 3Jun 2022: 5Jul 2022: 0Aug 2022: 0Sep 2022: 3Oct 2022: 1Nov 2022: 2Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 1Dec 2024: 32025Jan 2025: 3Feb 2025: 1Mar 2025: 13Apr 2025: 5May 2025: 0Jun 2025: 2Jul 2025: 1Aug 2025: 5Sep 2025: 3Oct 2025: 2Nov 2025: 6Dec 2025: 12026Jan 2026: 0Feb 2026: 3Mar 2026: 3Apr 2026: 2May 2026: 2Jun 2026: 1Jul 2026: 4Aug 2026: 3

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

032642011: 5520112012: 362013: 1920132014: 432015: 1820152016: 422017: 5020172018: 642019: 5120192020: 502021: 2720212022: 202024: 420242025: 422026: 182026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.5%8
Malfunction98.5%531
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%539
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 118,290 reports carrying product code GEI. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke17432.3%14%
Failure to deliver energy11321%1.3%
Electrical /electronic property probleman electrical or electronic problem397.2%2.7%
Detachment of device component336.1%3.5%
Device operates differently than expectedthe device behaved unexpectedly224.1%3.9%
Connection problema connection problem203.7%0.7%
Device inoperablethe device could not be used203.7%1.5%
Loss of powerthe device lost power193.5%0.4%
Intermittent continuity152.8%0.2%
Device stops intermittentlythe device stopped now and then132.4%0.3%
Crackthe device cracked122.2%0.5%
Detachment of device or device componentpart of the device came off91.7%3.8%
Failure to disconnect81.5%0%
Disconnection71.3%0.1%
Defective component61.1%0.3%
Difficult to removethe device was hard to remove61.1%0.7%
Material separation61.1%1.4%
Separation failure61.1%0%
Sticking61.1%1.5%
Insufficient device problem information50.9%2.8%

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 involvement6712.4%
Electric shockan electric shock10.2%
Surgical procedure10.2%

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

In context

MeasureHemoPro2 Extension CableProduct code GEIAll MAUDE reports
Reports539118,29026,136,888
Share of that pool—0.5%0%
Classified as death, per 1,000 reports049
Classified as injury1.5%16.7%36.2%
Classified as malfunction98.5%80.1%62.3%
Filed by the manufacturer100%92.4%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 GEI

BrandReportsLatest 12 monthsClassified as death
LigaSure8,2648790.2%
VasoView Hemopro 26,6336860%
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S4,5904030%
HF unit "ESG-400"2,6986640.1%
Valleylab2,0103530.3%
Vaso View Hemopro1,83800.1%
LigaSure Impact1,831720.3%
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip1,505380.3%
Thunderbeat 5mm 35cm Front-Actuated Grip1,24700.2%
Valleylab Ft101,20320.3%
Vasoview Hemopro1,18700%
Ligasure Advance Pistol Grip97000%
Ligasure Atlas Handswitching 37cm92400.2%
Edge8591710.1%
Force Fx780220.4%

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 HemoPro2 Extension Cable reports

How many FDA reports name HemoPro2 Extension Cable?

539 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 30 in the latest 12 months.

What kinds of events are reported?

malfunction (98.5%) and injury (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (32.3%), failure to deliver energy (21%), electrical /electronic property problem (7.2%), detachment of device component (6.1%) and device operates differently than expected (4.1%). 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 HemoPro2 Extension Cable 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.