Devices › Insufflator, laparoscopic
Device brand name · High flow insufflation unit
High Flow Insufflation Unit: medical device reports filed with FDA
5,780 reports name it, 2013–2026. Manufacturer given most often on reports: Shirakawa Olympus. Product code HIF.
- 5,780
- device reports naming the brand
- 0% of all MAUDE reports · about 428 a year
- 1,864
- reports, 12 months to August 2026
- 1,063 in the 12 months before
- 98.2%
- classified as malfunction
- 88.1% across the product code
- 0.1%
- classified as death, as reported
- 7 reports · not verified by FDA
5,780 medical device reports received by FDA name the brand "High Flow Insufflation Unit" (high flow insufflation unit); the manufacturer given most often on reports is Shirakawa Olympus; received from January 2013 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1,864 reports arrived in the 12 months to August 2026, up 75% from 1,063 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 (98.2%), injury (1.7%) and death (0.1%); 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 (12.1%), gas/air leak (8.1%) and no display/image (8.1%). The patient problems coded most often are no patient involvement, cardiac arrest and bradycardia. 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
Who filed the report
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 | 698 | 12.1% | 10.7% |
| Gas/air leak | 471 | 8.1% | 7% |
| No display/image | 466 | 8.1% | 6.1% |
| Display or visual feedback problem | 362 | 6.3% | 4.8% |
| Failure to power up | 348 | 6% | 4.6% |
| Electrical /electronic property probleman electrical or electronic problem | 311 | 5.4% | 4.1% |
| Breakthe device broke | 219 | 3.8% | 3.9% |
| Circuit failure | 194 | 3.4% | 2.6% |
| Output problem | 188 | 3.3% | 2.9% |
| Unexpected shutdown | 182 | 3.1% | 2.7% |
| No visual prompts/feedback | 177 | 3.1% | 2.3% |
| Gas output problem | 152 | 2.6% | 2.6% |
| Power problem | 151 | 2.6% | 2.1% |
| No device output | 149 | 2.6% | 2% |
| Loss of powerthe device lost power | 142 | 2.5% | 2.6% |
| Leak/splashthe device leaked | 141 | 2.4% | 2.1% |
| Decrease in pressure | 136 | 2.4% | 2.4% |
| Insufficient flow or under infusion | 133 | 2.3% | 1.8% |
| No flow | 121 | 2.1% | 1.8% |
| Audible prompt/feedback problem | 119 | 2.1% | 1.6% |
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 |
|---|---|---|
| No patient involvement | 17 | 0.3% |
| Cardiac arrestthe heart stopped | 16 | 0.3% |
| Bradycardiaslow heart rate | 10 | 0.2% |
| Injurya physical injury | 9 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 7 | 0.1% |
| Abdominal distention | 6 | 0.1% |
| Low blood pressure/ hypotension | 6 | 0.1% |
| Air embolism | 5 | 0.1% |
| Low oxygen saturation | 3 | 0.1% |
| Pneumothoraxa collapsed lung | 3 | 0.1% |
| Tachycardiafast heart rate | 3 | 0.1% |
| Abdominal painstomach or belly pain | 2 | 0% |
| Asystole | 2 | 0% |
| Dyspneashortness of breath | 2 | 0% |
| Hemorrhage/blood loss/bleeding | 2 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | High Flow Insufflation Unit | Product code HIF | All MAUDE reports |
|---|---|---|---|
| Reports | 5,780 | 7,602 | 26,136,888 |
| Share of that pool | — | 76% | 0% |
| Classified as death, per 1,000 reports | 1 | 4 | 9 |
| Classified as injury | 1.7% | 10.8% | 36.2% |
| Classified as malfunction | 98.2% | 88.1% | 62.3% |
| Filed by the manufacturer | 100% | 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 |
|---|---|---|---|
| Airseal | 493 | 109 | 0.8% |
| Endoscopic Co2 Regulation Unit | 160 | 16 | 0% |
| 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 High Flow Insufflation Unit reports
How many FDA reports name High Flow Insufflation Unit?
5,780 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,864 in the latest 12 months.
What kinds of events are reported?
malfunction (98.2%), injury (1.7%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pressure problem (12.1%), gas/air leak (8.1%), no display/image (8.1%), display or visual feedback problem (6.3%) and failure to power up (6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and distributor reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that High Flow Insufflation 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.