Device brand name · Co2 regulation unit

Endoscopic Co2 Regulation Unit: medical device reports filed with FDA

160 reports name it, 2016–2026. Manufacturer given most often on reports: Olympus Medical Systems. Product code HIF.

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.

160
device reports naming the brand: 0% of all MAUDE reports · about 16 a year; 16
reports, 12 months to August 2026: 23 in the 12 months before; 55.6%
classified as malfunction: 88.1% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 160 reports that name the brand "Endoscopic Co2 Regulation Unit" (co2 regulation unit), received between April 2016 and August 2026; the manufacturer given most often on reports is Olympus Medical Systems. Spellings of one product vary from report to report.

16 reports arrived in the 12 months to August 2026, down 30% from 23 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 (55.6%) and injury (44.4%); across all insufflator, laparoscopic reports (product code HIF) death is recorded in 0.4% and malfunction in 88.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are pressure problem (13.1%), backflow (8.1%) and increase in pressure (6.3%). The patient problems coded most often are injury, bowel perforation and abdominal pain. 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.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury44.4%71

Malfunction55.6%89

Other0%0

Not given0%0

Who filed the report

Manufacturer report94.4%151

Voluntary report0%0

User facility report0%0

Distributor report5%8

Not given0.6%1

Grey bar: all 7,602 reports carrying product code HIF. 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
Pressure problem	21	13.1%	10.7%
Backflow	13	8.1%	0.2%
Increase in pressure	10	6.3%	2.5%
Breakthe device broke	7	4.4%	3.9%
Defective devicethe device was defective	7	4.4%	0.7%
Device reprocessing problem	5	3.1%	0.1%
Insufficient device problem information	4	2.5%	1.4%
Noise, audible	4	2.5%	1.1%
Excess flow or over-infusion	3	1.9%	0.7%
Infusion or flow problema problem with flow or infusion	3	1.9%	1.6%
Contamination /decontamination problem	2	1.3%	0.1%
Corrodedthe device corroded	2	1.3%	0.8%
Gas output problem	2	1.3%	2.6%
Gas/air leak	2	1.3%	7%
Positioning failure	2	1.3%	0%
Pumping problem	2	1.3%	0%
Device difficult to program or calibrate	1	0.6%	0%
Fluid/blood leak	1	0.6%	0.2%
Inaccurate flow rate	1	0.6%	0.6%
Inflation problem	1	0.6%	0.8%

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)	Reports	Share
Injurya physical injury	17	10.6%
Bowel perforation	14	8.8%
Abdominal painstomach or belly pain	5	3.1%
Appropriate clinical signs, symptoms and conditions term/code not available	4	2.5%
Hemorrhage/blood loss/bleeding	3	1.9%
Perforation	3	1.9%
Pneumothoraxa collapsed lung	3	1.9%
Abdominal distention	2	1.3%
Fever	2	1.3%
No patient involvement	2	1.3%
Pneumoperitoneum	2	1.3%
Airway obstruction	1	0.6%
Chest painchest pain	1	0.6%
Gastrointestinal hemorrhage	1	0.6%
Loss of consciousnesspassing out	1	0.6%

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

In context

Measure	Endoscopic Co2 Regulation Unit	Product code HIF	All MAUDE reports
Reports	160	7,602	26,136,888
Share of that pool	—	2.1%	0%
Classified as death, per 1,000 reports	0	4	9
Classified as injury	44.4%	10.8%	36.2%
Classified as malfunction	55.6%	88.1%	62.3%
Filed by the manufacturer	94.4%	97%	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 HIF

Brand	Reports	Latest 12 months	Classified as death
High Flow Insufflation Unit	5,780	1,864	0.1%
Airseal	493	109	0.8%
Deroyal	587	14	0.7%
Karl Storz	633	0	2.1%
Stryker	559	5	1.3%
Unknown_Endoscopy_Product	241	22	0.4%

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 Endoscopic Co2 Regulation Unit reports

How many FDA reports name Endoscopic Co2 Regulation Unit?

160 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 16 in the latest 12 months.

What kinds of events are reported?

malfunction (55.6%) and injury (44.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

pressure problem (13.1%), backflow (8.1%), increase in pressure (6.3%), break (4.4%) and defective device (4.4%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (94.4%) and distributor reports (5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Endoscopic Co2 Regulation Unit 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.