Devices › Duodenoscope and accessories, flexible/rigid
Device brand name · Distal cover
Single Use Distal Cover: medical device reports filed with FDA
1,025 reports name it, 2019–2026. Manufacturer given most often on reports: Olympus Medical Systems Hinode Plant. Product code FDT.
- 1,025
- device reports naming the brand
- 0% of all MAUDE reports · about 145 a year
- 102
- reports, 12 months to August 2026
- 148 in the 12 months before
- 58%
- classified as malfunction
- 88.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,025 reports that name the brand "Single Use Distal Cover" (distal cover), received between June 2019 and August 2026; the manufacturer given most often on reports is Olympus Medical Systems Hinode Plant. Spellings of one product vary from report to report.
102 reports arrived in the 12 months to August 2026, down 31% from 148 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 (58%) and injury (42%); across all duodenoscope and accessories, flexible/rigid reports (product code FDT) death is recorded in 0.7% and malfunction in 88.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (73.4%), break (8.6%) and device fell (4.4%). The patient problems coded most often are foreign body in patient, laceration(s) and hemorrhage/blood loss/bleeding. 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 25,159 reports carrying product code FDT. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 752 | 73.4% | 9.3% |
| Breakthe device broke | 88 | 8.6% | 6.3% |
| Device fell | 45 | 4.4% | 0.4% |
| Crackthe device cracked | 44 | 4.3% | 9.6% |
| Separation problem | 40 | 3.9% | 0.5% |
| Material separation | 38 | 3.7% | 1.7% |
| Contamination | 22 | 2.1% | 3% |
| Material split, cut or torn | 21 | 2% | 1.5% |
| Device dislodged or dislocated | 10 | 1% | 0.2% |
| Device contamination with body fluid | 7 | 0.7% | 0.1% |
| Material integrity problema problem with the device material | 6 | 0.6% | 0.3% |
| Difficult to advance | 4 | 0.4% | 0.2% |
| Entrapment of device | 4 | 0.4% | 0.1% |
| Structural problem | 4 | 0.4% | 0.1% |
| Device contamination with chemical or other material | 3 | 0.3% | 1.4% |
| Insufficient device problem information | 3 | 0.3% | 0.7% |
| Loose or intermittent connection | 3 | 0.3% | 0.1% |
| Positioning failure | 3 | 0.3% | 0.2% |
| Contamination /decontamination problem | 2 | 0.2% | 1.2% |
| Defective component | 2 | 0.2% | 0.1% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 111 | 10.8% |
| Laceration(s) | 39 | 3.8% |
| Hemorrhage/blood loss/bleeding | 29 | 2.8% |
| Perforation | 11 | 1.1% |
| Coughcough | 8 | 0.8% |
| Laceration(s) of esophagus | 7 | 0.7% |
| Airway obstruction | 6 | 0.6% |
| Vomitingbeing sick | 6 | 0.6% |
| Device embedded in tissue or plaque | 5 | 0.5% |
| Low oxygen saturation | 5 | 0.5% |
| Tissue breakdown | 5 | 0.5% |
| Tissue damage | 5 | 0.5% |
| Discomfortdiscomfort | 4 | 0.4% |
| Painpain, site not specified | 4 | 0.4% |
| Abdominal painstomach or belly pain | 3 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Single Use Distal Cover | Product code FDT | All MAUDE reports |
|---|---|---|---|
| Reports | 1,025 | 25,159 | 26,136,888 |
| Share of that pool | — | 4.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 7 | 9 |
| Classified as injury | 42% | 10.5% | 36.2% |
| Classified as malfunction | 58% | 88.5% | 62.3% |
| Filed by the manufacturer | 87.8% | 97.6% | 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 FDT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Evis Lucera Duodenovideoscope | 3,630 | 1,681 | 0.8% |
| Pentax | 47,288 | 2,443 | 0.1% |
| Evis Lucera Elite Duodenovideoscope | 1,370 | 882 | 0.2% |
| Evis Exera Duodenovideoscope | 966 | 74 | 2% |
| Duodenovideoscope | 874 | 289 | 0.7% |
| EXALT Model D Single-Use Duodenoscope | 306 | 39 | 0.7% |
| CRE Wireguided | 718 | 56 | 0.3% |
| Olympus | 2,240 | 9 | 2.5% |
| Single Use Ligating Device | 594 | 170 | 0% |
| THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip | 1,505 | 38 | 0.3% |
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 Single Use Distal Cover reports
How many FDA reports name Single Use Distal Cover?
1,025 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 102 in the latest 12 months.
What kinds of events are reported?
malfunction (58%) and injury (42%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (73.4%), break (8.6%), device fell (4.4%), crack (4.3%) and separation problem (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (87.8%), distributor reports (9.7%) and voluntary reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Single Use Distal Cover 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.