Devices › Colonoscope and accessories, flexible/rigid
Device brand name · Video colonocope - i10 standard
Pentax: medical device reports filed with FDA
47,288 reports name it, 1996–2026. Manufacturer given most often on reports: Hoya Pentax Tokyo Office. Product code FDF.
- 47,288
- device reports naming the brand
- 0.2% of all MAUDE reports · about 1,585 a year
- 2,443
- reports, 12 months to August 2026
- 5,272 in the 12 months before
- 98.4%
- classified as malfunction
- 98.1% across the product code
- 0.1%
- classified as death, as reported
- 33 reports · not verified by FDA
FDA's MAUDE database holds 47,288 reports that name the brand "Pentax" (video colonocope - i10 standard), received between September 1996 and August 2026; the manufacturer given most often on reports is Hoya Pentax Tokyo Office. Spellings of one product vary from report to report.
2,443 reports arrived in the 12 months to August 2026, down 54% from 5,272 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 (98.4%), injury (1.5%) and death (0.1%); across all colonoscope and accessories, flexible/rigid reports (product code FDF) death is recorded in 0.1% and malfunction in 98.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (22.7%), fluid/blood leak (15.1%) and obstruction of flow (9.9%). The patient problems coded most often are no patient involvement, bacterial infection 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 81,401 reports carrying product code FDF. 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 |
|---|---|---|---|
| Breakthe device broke | 10,732 | 22.7% | 6% |
| Fluid/blood leak | 7,163 | 15.1% | 2.9% |
| Obstruction of flow | 4,704 | 9.9% | 3.1% |
| Erratic or intermittent display | 4,416 | 9.3% | 5.8% |
| Optical obstruction | 4,158 | 8.8% | 3.2% |
| No display/image | 4,127 | 8.7% | 10.4% |
| Detachment of device or device componentpart of the device came off | 2,614 | 5.5% | 2.1% |
| Loss of or failure to bond | 1,718 | 3.6% | 0% |
| Optical distortion | 1,359 | 2.9% | 0.9% |
| Failure to clean adequately | 1,079 | 2.3% | 28.5% |
| Unintended movement | 954 | 2% | 0.6% |
| Loose or intermittent connection | 756 | 1.6% | 0.3% |
| Poor quality image | 559 | 1.2% | 6.2% |
| Computer software problema software problem | 424 | 0.9% | 0% |
| Device reprocessing problem | 375 | 0.8% | 6.3% |
| Material split, cut or torn | 360 | 0.8% | 0.4% |
| Component missing | 296 | 0.6% | 0.2% |
| Microbial contamination of device | 280 | 0.6% | 6.2% |
| Optical problem | 169 | 0.4% | 0.2% |
| Fracturea broken bone | 132 | 0.3% | 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 |
|---|---|---|
| No patient involvement | 247 | 0.5% |
| Bacterial infectiona bacterial infection | 239 | 0.5% |
| Device embedded in tissue or plaque | 59 | 0.1% |
| Foreign body in patientpart of a device left in the patient | 52 | 0.1% |
| Hemorrhage/blood loss/bleeding | 28 | 0.1% |
| Sepsisa severe body-wide response to infection | 27 | 0.1% |
| Laceration(s) | 24 | 0.1% |
| Painpain, site not specified | 23 | 0% |
| Internal organ perforation | 19 | 0% |
| Deaththe patient died; cause not stated by this term | 17 | 0% |
| Fungal infectiona fungal infection | 16 | 0% |
| Perforation | 16 | 0% |
| Bowel perforation | 14 | 0% |
| Abdominal painstomach or belly pain | 9 | 0% |
| Chemical exposure | 8 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pentax | Product code FDF | All MAUDE reports |
|---|---|---|---|
| Reports | 47,288 | 81,401 | 26,136,888 |
| Share of that pool | — | 58.1% | 0.2% |
| Classified as death, per 1,000 reports | 1 | 1 | 9 |
| Classified as injury | 1.5% | 1.7% | 36.2% |
| Classified as malfunction | 98.4% | 98.1% | 62.3% |
| Filed by the manufacturer | 99.3% | 99.4% | 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 FDF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Evis Lucera Elite Colonovideoscope | 16,369 | 9,695 | 0% |
| Colonovideoscope | 9,419 | 5,712 | 0% |
| Evis Lucera Colonovideoscope | 2,171 | 1,019 | 0% |
| Evis Exera Lll Colonovideoscope | 1,052 | 0 | 0.2% |
| PENTAX Medical | 1,349 | 807 | 0.3% |
| Olympus | 2,240 | 9 | 2.5% |
| Evis Lusera Colonovideoscope | 411 | 31 | 0% |
| Maintenance Unit | 419 | 76 | 0% |
| Video System Center | 3,431 | 838 | 0% |
| Imagina | 263 | 0 | 0% |
| CRE Wireguided | 718 | 56 | 0.3% |
| Ultrasonic Gastrovideoscope | 1,885 | 902 | 0.2% |
| Visera Video System Center | 341 | 73 | 0% |
| Ultrasonic Probe | 787 | 212 | 0.5% |
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 Pentax reports
How many FDA reports name Pentax?
47,288 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2,443 in the latest 12 months.
What kinds of events are reported?
malfunction (98.4%), injury (1.5%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (22.7%), fluid/blood leak (15.1%), obstruction of flow (9.9%), erratic or intermittent display (9.3%) and optical obstruction (8.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%), distributor reports (0.7%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Pentax 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.