Devices › Endoscopic access overtube, gastroenterology-urology
Device brand name · Endoscopic access overtube gastroenterology-urology
Navigator Hd: medical device reports filed with FDA
166 reports name it, 2013–2025. Manufacturer given most often on reports: Boston Scientific. Product code FED.
- 166
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 3
- reports, 12 months to August 2026
- 9 in the 12 months before
- 71.1%
- classified as malfunction
- 72.1% across the product code
- 0.6%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 166 reports that name the brand "Navigator Hd" (endoscopic access overtube gastroenterology-urology), received between April 2013 and December 2025; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
3 reports arrived in the 12 months to August 2026, down 67% from 9 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 (71.1%), injury (27.7%) and death (0.6%); across all endoscopic access overtube, gastroenterology-urology reports (product code FED) death is recorded in 1.7% and malfunction in 72.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material split, cut or torn (16.3%), peeled/delaminated (15.7%) and material integrity problem (11.4%). The patient problems coded most often are perforation, tissue damage and internal organ perforation. 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 1,322 reports carrying product code FED. 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 |
|---|---|---|---|
| Material split, cut or torn | 27 | 16.3% | 3.9% |
| Peeled/delaminated | 26 | 15.7% | 6.4% |
| Material integrity problema problem with the device material | 19 | 11.4% | 2% |
| Torn material | 12 | 7.2% | 0.8% |
| Breakthe device broke | 11 | 6.6% | 15.7% |
| Detachment of device or device componentpart of the device came off | 5 | 3% | 2.3% |
| Device contamination with chemical or other material | 5 | 3% | 2.3% |
| Fracturea broken bone | 5 | 3% | 0.8% |
| Material deformation | 4 | 2.4% | 1.5% |
| Partial blockage | 4 | 2.4% | 0.5% |
| Tear, rip or hole in device packaging | 4 | 2.4% | 0.5% |
| Defective devicethe device was defective | 3 | 1.8% | 0.4% |
| Unsealed device packaging | 3 | 1.8% | 1.4% |
| Device damaged prior to receipt by user | 2 | 1.2% | 0.2% |
| Difficult to insertthe device was hard to insert | 2 | 1.2% | 4.8% |
| Device contaminated during manufacture or shipping | 1 | 0.6% | 0.7% |
| Device packaging compromised | 1 | 0.6% | 0.2% |
| Difficult to removethe device was hard to remove | 1 | 0.6% | 2.7% |
| Failure to advance | 1 | 0.6% | 0.2% |
| Packaging problem | 1 | 0.6% | 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 |
|---|---|---|
| Perforation | 9 | 5.4% |
| Tissue damage | 8 | 4.8% |
| Internal organ perforation | 5 | 3% |
| Injurya physical injury | 3 | 1.8% |
| Hematuria | 2 | 1.2% |
| No patient involvement | 2 | 1.2% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.6% |
| Hemorrhage/blood loss/bleeding | 1 | 0.6% |
| Laceration(s) | 1 | 0.6% |
| Painpain, site not specified | 1 | 0.6% |
| Urinary retentionbeing unable to empty the bladder | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Navigator Hd | Product code FED | All MAUDE reports |
|---|---|---|---|
| Reports | 166 | 1,322 | 26,136,888 |
| Share of that pool | — | 12.6% | 0% |
| Classified as death, per 1,000 reports | 6 | 17 | 9 |
| Classified as injury | 27.7% | 18.9% | 36.2% |
| Classified as malfunction | 71.1% | 72.1% | 62.3% |
| Filed by the manufacturer | 97% | 84.1% | 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 FED
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Karl Storz | 633 | 0 | 2.1% |
| Inner sheath, for 26 Fr. outer sheath | 2,002 | 533 | 0% |
| Resection sheath, 24 Fr. | 759 | 170 | 0.1% |
| 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 Navigator Hd reports
How many FDA reports name Navigator Hd?
166 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
malfunction (71.1%), injury (27.7%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material split, cut or torn (16.3%), peeled/delaminated (15.7%), material integrity problem (11.4%), torn material (7.2%) and break (6.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Navigator Hd 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.