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Device brand name · Hemostatic device for endoscopic gastrointestinal use
Hemospray Endoscopic Hemostat: medical device reports filed with FDA
1,052 reports name it, 2018–2026. Manufacturer given most often on reports: Wilson-Cook Medical. Product code QAU.
- 1,052
- device reports naming the brand
- 0% of all MAUDE reports · about 130 a year
- 116
- reports, 12 months to August 2026
- 151 in the 12 months before
- 83.6%
- classified as malfunction
- 84.1% across the product code
- 0.9%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 1,052 reports that name the brand "Hemospray Endoscopic Hemostat" (hemostatic device for endoscopic gastrointestinal use), received between June 2018 and August 2026; the manufacturer given most often on reports is Wilson-Cook Medical. Spellings of one product vary from report to report.
116 reports arrived in the 12 months to August 2026, down 23% from 151 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 (83.6%), injury (15.6%) and death (0.9%); across all hemostatic device for endoscopic gastrointestinal use reports (product code QAU) death is recorded in 0.8% and malfunction in 84.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are activation failure (55%), failure to fire (20.1%) and obstruction of flow (13.5%). The patient problems coded most often are gastrointestinal hemorrhage, no patient involvement and device embedded in tissue or plaque. 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 1,087 reports carrying product code QAU. 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 |
|---|---|---|---|
| Activation failure | 579 | 55% | 53.3% |
| Failure to fire | 211 | 20.1% | 19.1% |
| Obstruction of flow | 142 | 13.5% | 13.2% |
| Complete blockage | 94 | 8.9% | 10.1% |
| Fracturea broken bone | 62 | 5.9% | 5.7% |
| Improper or incorrect procedure or method | 52 | 4.9% | 4.8% |
| Device handling problem | 49 | 4.7% | 4.5% |
| Entrapment of device | 40 | 3.8% | 3.7% |
| Material twisted/bent | 23 | 2.2% | 2% |
| Gas/air leak | 22 | 2.1% | 2% |
| Positioning failure | 16 | 1.5% | 1.5% |
| Insufficient flow or under infusion | 13 | 1.2% | 1.2% |
| Failure to disconnect | 9 | 0.9% | 0.8% |
| Crackthe device cracked | 7 | 0.7% | 0.6% |
| Explosion | 7 | 0.7% | 0.6% |
| Infusion or flow problema problem with flow or infusion | 5 | 0.5% | 0.5% |
| Insufficient device problem information | 5 | 0.5% | 0.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 4 | 0.4% | 0.3% |
| Human-device interface problem | 4 | 0.4% | 0.4% |
| Partial blockage | 4 | 0.4% | 0.4% |
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 |
|---|---|---|
| Gastrointestinal hemorrhage | 123 | 11.7% |
| No patient involvement | 43 | 4.1% |
| Device embedded in tissue or plaque | 28 | 2.7% |
| Hemorrhage/blood loss/bleeding | 17 | 1.6% |
| Hemostasis | 11 | 1% |
| Painpain, site not specified | 11 | 1% |
| Perforation | 11 | 1% |
| Deaththe patient died; cause not stated by this term | 3 | 0.3% |
| Exsanguination | 3 | 0.3% |
| Laceration(s) | 3 | 0.3% |
| Abdominal distention | 2 | 0.2% |
| Abdominal painstomach or belly pain | 2 | 0.2% |
| Bowel perforation | 2 | 0.2% |
| Bruise/contusion | 2 | 0.2% |
| Cardiac arrestthe heart stopped | 2 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hemospray Endoscopic Hemostat | Product code QAU | All MAUDE reports |
|---|---|---|---|
| Reports | 1,052 | 1,087 | 26,136,888 |
| Share of that pool | — | 96.8% | 0% |
| Classified as death, per 1,000 reports | 9 | 8 | 9 |
| Classified as injury | 15.6% | 15.1% | 36.2% |
| Classified as malfunction | 83.6% | 84.1% | 62.3% |
| Filed by the manufacturer | 99.6% | 98.3% | 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."
Questions about Hemospray Endoscopic Hemostat reports
How many FDA reports name Hemospray Endoscopic Hemostat?
1,052 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 116 in the latest 12 months.
What kinds of events are reported?
malfunction (83.6%), injury (15.6%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
activation failure (55%), failure to fire (20.1%), obstruction of flow (13.5%), complete blockage (8.9%) and fracture (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Hemospray Endoscopic Hemostat 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.