Hugo RAS System: medical device reports filed with FDA

1,428 reports name it, 2025–2026. Manufacturer given most often on reports: Surgical. Product code SCV.

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.

1,428
device reports naming the brand: 0% of all MAUDE reports · about 1,428 a year; 1,428
reports, 12 months to August 2026: 0 in the 12 months before; 98.3%
classified as malfunction: 98.1% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 1,428 reports that name the brand "Hugo RAS System" (modular electromechanical surgical system), received between December 2025 and August 2026; the manufacturer given most often on reports is Surgical. Spellings of one product vary from report to report.

1,428 reports arrived in the 12 months to August 2026, with 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 (98.3%) and injury (1.7%); across all modular electromechanical surgical system reports (product code SCV) death is recorded in 0% and malfunction in 98.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are application program freezes or fails to launch (24.6%), communication or transmission problem (22.1%) and display or visual feedback problem (17.6%). The patient problems coded most often are hemorrhage/blood loss/bleeding, tissue breakdown and laceration(s). 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

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.

Event type and report source

Event type, as classified on the report

Death0%0

Injury1.7%24

Malfunction98.3%1,404

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%1,428

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 1,812 reports carrying product code SCV. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Application program freezes or fails to launch	351	24.6%	21.1%
Communication or transmission problemthe device could not communicate or transmit	315	22.1%	19.6%
Display or visual feedback problem	252	17.6%	15.9%
Breakthe device broke	235	16.5%	15.5%
Intermittent communication failure	208	14.6%	13.1%
Difficult to removethe device was hard to remove	160	11.2%	10.5%
Difficult or delayed activation	123	8.6%	8.2%
Failure to calibrate	109	7.6%	6.8%
Device fell	80	5.6%	5%
Positioning problem	63	4.4%	3.9%
Activation problem	62	4.3%	4.1%
No display/image	48	3.4%	3.5%
Component or accessory incompatibility	40	2.8%	2.6%
Device displays incorrect message	37	2.6%	2.3%
Unintended collision	31	2.2%	2%
Unintended system motionthe device moved when it should not have	30	2.1%	1.9%
Display difficult to read	23	1.6%	1.3%
Device alarm system	21	1.5%	1.4%
Complete loss of power	19	1.3%	1.2%
Failure to cut	19	1.3%	1.2%

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)	Reports	Share
Hemorrhage/blood loss/bleeding	10	0.7%
Tissue breakdown	10	0.7%
Laceration(s)	8	0.6%
Foreign body in patientpart of a device left in the patient	5	0.4%
Unintended radiation exposure	5	0.4%
Bowel perforation	4	0.3%
Bowel burn	2	0.1%
Full thickness (third degree) burn	2	0.1%

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

In context

Measure	Hugo RAS System	Product code SCV	All MAUDE reports
Reports	1,428	1,812	26,136,888
Share of that pool	—	78.8%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	1.7%	1.8%	36.2%
Classified as malfunction	98.3%	98.1%	62.3%
Filed by the manufacturer	100%	100%	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 SCV

Brand	Reports	Latest 12 months	Classified as death
Versius Surgical System	190	190	0%

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 Hugo RAS System reports

How many FDA reports name Hugo RAS System?

1,428 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,428 in the latest 12 months.

What kinds of events are reported?

malfunction (98.3%) and injury (1.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

application program freezes or fails to launch (24.6%), communication or transmission problem (22.1%), display or visual feedback problem (17.6%), break (16.5%) and intermittent communication failure (14.6%). 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 Hugo RAS System 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.