Devices › System, x-ray, tomography, computed
Device brand name · Electromagnetic navigation bronchoscopy
Superdimension Inreach System: medical device reports filed with FDA
398 reports name it, 2011–2021. Manufacturer given most often on reports: Superdimension. Product code JAK.
- 398
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 26.4%
- classified as malfunction
- 54.1% across the product code
- 26.6%
- classified as death, as reported
- 106 reports · not verified by FDA
FDA's MAUDE database holds 398 reports that name the brand "Superdimension Inreach System" (electromagnetic navigation bronchoscopy), received between March 2011 and October 2021; the manufacturer given most often on reports is Superdimension. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (47%), death (26.6%) and malfunction (26.4%); across all system, x-ray, tomography, computed reports (product code JAK) death is recorded in 4.2% and malfunction in 54.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (7.8%), device operates differently than expected (6.8%) and device displays incorrect message (2%). The patient problems coded most often are death, pneumothorax and blood loss. 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 5,268 reports carrying product code JAK. 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 |
|---|---|---|---|
| Insufficient device problem information | 31 | 7.8% | 5.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 27 | 6.8% | 8.9% |
| Device displays incorrect message | 8 | 2% | 6.3% |
| Connection problema connection problem | 6 | 1.5% | 1.3% |
| Computer operating system problem | 5 | 1.3% | 0.5% |
| Data problem | 5 | 1.3% | 0.5% |
| Difficult to position | 5 | 1.3% | 0.2% |
| Failure to power up | 5 | 1.3% | 0.3% |
| Application interface becomes non-functional or program exits abnormally | 4 | 1% | 0.5% |
| Application network problem | 4 | 1% | 0.9% |
| Image display error/artifact | 4 | 1% | 1.9% |
| Incorrect measurementthe device measured wrongly | 4 | 1% | 0.5% |
| Application program problem | 3 | 0.8% | 3.8% |
| Computer software problema software problem | 3 | 0.8% | 2.1% |
| Device inoperablethe device could not be used | 3 | 0.8% | 1.3% |
| Incorrect, inadequate or imprecise result or readings | 3 | 0.8% | 0.2% |
| Programming issue | 3 | 0.8% | 0.3% |
| Device difficult to setup or prepare | 2 | 0.5% | 0% |
| Device sensing problem | 2 | 0.5% | 0.4% |
| Electromagnetic interference | 2 | 0.5% | 0% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 104 | 26.1% |
| Pneumothoraxa collapsed lung | 93 | 23.4% |
| Blood loss | 20 | 5% |
| Painpain, site not specified | 16 | 4% |
| Respiratory failurethe lungs could not supply enough oxygen | 4 | 1% |
| Cardiac arrestthe heart stopped | 3 | 0.8% |
| Hemorrhage/blood loss/bleeding | 3 | 0.8% |
| Hypoxialow oxygen | 3 | 0.8% |
| Low oxygen saturation | 3 | 0.8% |
| Decreased respiratory rate | 2 | 0.5% |
| Infarction, cerebral | 2 | 0.5% |
| Adult respiratory distress syndrome | 1 | 0.3% |
| Atrial tachycardia | 1 | 0.3% |
| Bacterial infectiona bacterial infection | 1 | 0.3% |
| Chest painchest pain | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Superdimension Inreach System | Product code JAK | All MAUDE reports |
|---|---|---|---|
| Reports | 398 | 5,268 | 26,136,888 |
| Share of that pool | — | 7.6% | 0% |
| Classified as death, per 1,000 reports | 266 | 42 | 9 |
| Classified as injury | 47% | 28.9% | 36.2% |
| Classified as malfunction | 26.4% | 54.1% | 62.3% |
| Filed by the manufacturer | 100% | 89.7% | 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 JAK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Illumisite | 380 | 70 | 0.5% |
| Brilliance 64 | 357 | 0 | 0.6% |
| Brilliance 16 Air | 249 | 0 | 0.4% |
| Ict | 222 | 0 | 0.5% |
| Superdimension Inreach Bronchus System | 213 | 0 | 14.1% |
| Superdimension | 227 | 5 | 7% |
| Edge | 859 | 171 | 0.1% |
| Toshiba | 158 | 0 | 1.9% |
| Acist | 348 | 14 | 10.6% |
| Philips | 190 | 0 | 6.3% |
| Artis zee biplane | 182 | 7 | 1.1% |
| Artis Zee Ceiling | 209 | 4 | 0.5% |
| Bd Vacutainer Push Button Blood Collection Set With Pre-Attached Holder | 206 | 0 | 0% |
| BD Vacutainer Safety-Lok Blood Collection Set | 819 | 144 | 0% |
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 Superdimension Inreach System reports
How many FDA reports name Superdimension Inreach System?
398 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (47%), death (26.6%) and malfunction (26.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (7.8%), device operates differently than expected (6.8%), device displays incorrect message (2%), connection problem (1.5%) and computer operating system problem (1.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Superdimension Inreach System 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.