Devices › Insufflator, automatic carbon-dioxide for endoscope
Device brand name · Endoflator 50
Endoflator 50: medical device reports filed with FDA
231 reports name it, 2021–2026. Manufacturer given most often on reports: Karl Storz Se & Kg. Product code FCX.
- 231
- device reports naming the brand
- 0% of all MAUDE reports · about 42 a year
- 107
- reports, 12 months to August 2026
- 83 in the 12 months before
- 84.8%
- classified as malfunction
- 70.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 231 reports that name the brand "Endoflator 50" (endoflator 50), received between January 2021 and August 2026; the manufacturer given most often on reports is Karl Storz Se & Kg. Spellings of one product vary from report to report.
107 reports arrived in the 12 months to August 2026, up 29% from 83 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 (84.8%) and injury (15.2%); across all insufflator, automatic carbon-dioxide for endoscope reports (product code FCX) death is recorded in 1.1% and malfunction in 70.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are defective component (16%), insufficient device problem information (15.6%) and gas output problem (13.4%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, bradycardia and foreign body in patient. 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 551 reports carrying product code FCX. 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 |
|---|---|---|---|
| Defective component | 37 | 16% | 8.5% |
| Insufficient device problem information | 36 | 15.6% | 15.8% |
| Gas output problem | 31 | 13.4% | 8.2% |
| Electrical /electronic property probleman electrical or electronic problem | 26 | 11.3% | 5.3% |
| Output problem | 22 | 9.5% | 7.4% |
| Unexpected shutdown | 22 | 9.5% | 4.9% |
| Device alarm system | 12 | 5.2% | 3.1% |
| Inflation problem | 9 | 3.9% | 3.1% |
| Pumping stopped | 9 | 3.9% | 2.5% |
| Display or visual feedback problem | 6 | 2.6% | 1.5% |
| Pressure problem | 6 | 2.6% | 6.2% |
| Complete loss of power | 5 | 2.2% | 1.1% |
| Detachment of device or device componentpart of the device came off | 4 | 1.7% | 0.7% |
| Infusion or flow problema problem with flow or infusion | 4 | 1.7% | 2% |
| Intermittent loss of power | 4 | 1.7% | 0.9% |
| Circuit failure | 3 | 1.3% | 0.7% |
| Gas/air leak | 3 | 1.3% | 1.8% |
| Improper flow or infusion | 3 | 1.3% | 1.5% |
| Mechanical problema mechanical problem | 3 | 1.3% | 1.3% |
| Decrease in pressure | 2 | 0.9% | 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 |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 1.7% |
| Bradycardiaslow heart rate | 3 | 1.3% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.9% |
| Pneumoperitoneum | 2 | 0.9% |
| Arrhythmia | 1 | 0.4% |
| Electric shockan electric shock | 1 | 0.4% |
| Intra-abdominal hemorrhage | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endoflator 50 | Product code FCX | All MAUDE reports |
|---|---|---|---|
| Reports | 231 | 551 | 26,136,888 |
| Share of that pool | — | 41.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 11 | 9 |
| Classified as injury | 15.2% | 22.9% | 36.2% |
| Classified as malfunction | 84.8% | 70.6% | 62.3% |
| Filed by the manufacturer | 93.1% | 85.7% | 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 FCX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| High Flow Insufflation Unit | 5,780 | 1,864 | 0.1% |
| Deroyal | 587 | 14 | 0.7% |
| Endoscopic Co2 Regulation Unit | 160 | 16 | 0% |
| Olympus | 2,240 | 9 | 2.5% |
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 Endoflator 50 reports
How many FDA reports name Endoflator 50?
231 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 107 in the latest 12 months.
What kinds of events are reported?
malfunction (84.8%) and injury (15.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
defective component (16%), insufficient device problem information (15.6%), gas output problem (13.4%), electrical /electronic property problem (11.3%) and output problem (9.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (93.1%) and distributor reports (6.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Endoflator 50 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.