Reported Reactions

Devices › Electrosurgical, cutting & coagulation & accessories

Device brand name · Electrosurgical cutting & coagulation & accessories

Vaso View Hemopro: medical device reports filed with FDA

1,838 reports name it, 2010–2019. Manufacturer given most often on reports: Maquet Cardiovascular. Product code GEI.

1,838
device reports naming the brand
0% of all MAUDE reports · about 115 a year
0
reports, 12 months to August 2026
0 in the 12 months before
86.7%
classified as malfunction
80.1% across the product code
0.1%
classified as death, as reported
2 reports · not verified by FDA

FDA's MAUDE database holds 1,838 reports that name the brand "Vaso View Hemopro" (electrosurgical cutting & coagulation & accessories), received between July 2010 and May 2019; the manufacturer given most often on reports is Maquet Cardiovascular. 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 (86.7%), injury (13.1%) and death (0.1%); 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 (15%), detachment of device component (7.9%) and device remains activated (7.6%). The patient problems coded most often are no patient involvement, foreign body, removal of and device embedded in tissue or plaque. 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 Vaso View Hemopro was received in the five years to August 2026; the latest was received in May 2019.

By year received

01523032010: 320102011: 12520112012: 18320122013: 30320132014: 19220142015: 15120152016: 18220162017: 26820172018: 25220182019: 1792019

Event type and report source

Event type, as classified on the report

Death0.1%2
Injury13.1%240
Malfunction86.7%1,593
Other0%0
Not given0.2%3

Who filed the report

Manufacturer report100%1,838
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 broke27615%14%
Detachment of device component1457.9%3.5%
Device remains activated1407.6%1.3%
Device operates differently than expectedthe device behaved unexpectedly1216.6%3.9%
Smoking1146.2%1.1%
Peeled/delaminated1045.7%3%
Self-activation or keying1035.6%2.3%
Failure to shut off1005.4%0.4%
Overheating of device744%1.3%
Material separation512.8%1.4%
Bent422.3%0.5%
Component falling402.2%1.3%
Failure to deliver energy362%1.3%
Thermal decomposition of device341.8%1%
Detachment of device or device componentpart of the device came off331.8%3.8%
Burst container or vessel271.5%0.2%
Crackthe device cracked271.5%0.5%
Failure to cut261.4%1.4%
Melted251.4%1.5%
Loose or intermittent connection241.3%0.3%

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 involvement532.9%
Foreign body, removal of191%
Device embedded in tissue or plaque140.8%
Tissue damage130.7%
Foreign body in patientpart of a device left in the patient110.6%
Burn(s)a burn70.4%
Hemorrhage/blood loss/bleeding70.4%
Air embolism30.2%
Blood loss30.2%
Cardiac arrestthe heart stopped20.1%
Deaththe patient died; cause not stated by this term20.1%
Low blood pressure/ hypotension20.1%
Blurred vision10.1%
Burn, thermal10.1%
Cardiac tamponade10.1%

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

In context

MeasureVaso View HemoproProduct code GEIAll MAUDE reports
Reports1,838118,29026,136,888
Share of that pool—1.6%0%
Classified as death, per 1,000 reports149
Classified as injury13.1%16.7%36.2%
Classified as malfunction86.7%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%
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%
Conmed900890.2%

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 Vaso View Hemopro reports

How many FDA reports name Vaso View Hemopro?

1,838 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 (86.7%), injury (13.1%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (15%), detachment of device component (7.9%), device remains activated (7.6%), device operates differently than expected (6.6%) and smoking (6.2%). 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 Vaso View Hemopro 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.