Devices › Insufflator, laparoscopic
Device brand name · Insufflator laparoscopic
Airseal: medical device reports filed with FDA
493 reports name it, 2016–2026. Manufacturer given most often on reports: W O M World Of Medicine. Product code HIF.
- 493
- device reports naming the brand
- 0% of all MAUDE reports · about 47 a year
- 109
- reports, 12 months to August 2026
- 313 in the 12 months before
- 45.2%
- classified as malfunction
- 88.1% across the product code
- 0.8%
- classified as death, as reported
- 4 reports · not verified by FDA
493 medical device reports received by FDA name the brand "Airseal" (insufflator laparoscopic); the manufacturer given most often on reports is W O M World Of Medicine; received from February 2016 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
109 reports arrived in the 12 months to August 2026, down 65% from 313 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 injury (54%), malfunction (45.2%) and death (0.8%); 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 material fragmentation (17.4%), gas output problem (5.9%) and loss of power (5.5%). The patient problems coded most often are air embolism, foreign body in patient and hypothermia. 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 |
|---|---|---|---|
| Material fragmentation | 86 | 17.4% | 0.5% |
| Gas output problem | 29 | 5.9% | 2.6% |
| Loss of powerthe device lost power | 27 | 5.5% | 2.6% |
| Unexpected shutdown | 13 | 2.6% | 2.7% |
| Insufficient device problem information | 7 | 1.4% | 1.4% |
| Detachment of device or device componentpart of the device came off | 6 | 1.2% | 0.9% |
| Material separation | 4 | 0.8% | 0% |
| Power problem | 4 | 0.8% | 2.1% |
| Complete loss of power | 3 | 0.6% | 0.5% |
| Increase in pressure | 3 | 0.6% | 2.5% |
| Intermittent loss of power | 3 | 0.6% | 1% |
| Unintended deflation | 3 | 0.6% | 0.1% |
| Device dislodged or dislocated | 2 | 0.4% | 0.1% |
| Circuit failure | 1 | 0.2% | 2.6% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.2% | 1% |
| Crackthe device cracked | 1 | 0.2% | 0.7% |
| Decrease in pressure | 1 | 0.2% | 2.4% |
| Defective alarm | 1 | 0.2% | 0.5% |
| Defective component | 1 | 0.2% | 1.4% |
| Defective devicethe device was defective | 1 | 0.2% | 0.7% |
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 |
|---|---|---|
| Air embolism | 208 | 42.2% |
| Foreign body in patientpart of a device left in the patient | 20 | 4.1% |
| Hypothermia | 10 | 2% |
| Pneumothoraxa collapsed lung | 7 | 1.4% |
| Stroke/cva | 5 | 1% |
| Embolism/embolus | 4 | 0.8% |
| Bradycardiaslow heart rate | 3 | 0.6% |
| Hemorrhage/blood loss/bleeding | 3 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.4% |
| Hyperthermia | 2 | 0.4% |
| Ischemia stroke | 2 | 0.4% |
| Necrosisdeath of tissue | 2 | 0.4% |
| Bowel perforation | 1 | 0.2% |
| Burn(s)a burn | 1 | 0.2% |
| Cardiac arrestthe heart stopped | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Airseal | Product code HIF | All MAUDE reports |
|---|---|---|---|
| Reports | 493 | 7,602 | 26,136,888 |
| Share of that pool | — | 6.5% | 0% |
| Classified as death, per 1,000 reports | 8 | 4 | 9 |
| Classified as injury | 54% | 10.8% | 36.2% |
| Classified as malfunction | 45.2% | 88.1% | 62.3% |
| Filed by the manufacturer | 88.6% | 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% |
| 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 Airseal reports
How many FDA reports name Airseal?
493 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 109 in the latest 12 months.
What kinds of events are reported?
injury (54%), malfunction (45.2%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material fragmentation (17.4%), gas output problem (5.9%), loss of power (5.5%), unexpected shutdown (2.6%) and insufficient device problem information (1.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (88.6%) and voluntary reports (2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Airseal 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.