Devices › Electrode, ph, stomach
Device brand name · Electrode ph stomach
Bravo: medical device reports filed with FDA
11,648 reports name it, 2003–2026. Manufacturer given most often on reports: Given Imaging Yoqneam. Product code FFT.
- 11,648
- device reports naming the brand
- 0% of all MAUDE reports · about 499 a year
- 568
- reports, 12 months to August 2026
- 434 in the 12 months before
- 93.1%
- classified as malfunction
- 92% across the product code
- 0%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 11,648 reports that name the brand "Bravo" (electrode ph stomach), received between March 2003 and August 2026; the manufacturer given most often on reports is Given Imaging Yoqneam. Spellings of one product vary from report to report.
568 reports arrived in the 12 months to August 2026, up 31% from 434 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 (93.1%), injury (6.7%) and other (0.1%); across all electrode, ph, stomach reports (product code FFT) death is recorded in 0.1% and malfunction in 92%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to adhere or bond (44.9%), positioning failure (30%) and loss of or failure to bond (6.9%). The patient problems coded most often are foreign body in patient, airway obstruction 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 12,898 reports carrying product code FFT. 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 |
|---|---|---|---|
| Failure to adhere or bond | 5,227 | 44.9% | 44.7% |
| Positioning failure | 3,495 | 30% | 28% |
| Loss of or failure to bond | 803 | 6.9% | 6.7% |
| Other (for use when an appropriate device code cannot be identified) | 609 | 5.2% | 4.7% |
| Separation failure | 589 | 5.1% | 4.7% |
| Detachment of device component | 456 | 3.9% | 3.7% |
| Detachment of device or device componentpart of the device came off | 217 | 1.9% | 1.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 208 | 1.8% | 2% |
| Failure to transmit record | 178 | 1.5% | 1.6% |
| Migration or expulsion of device | 167 | 1.4% | 1.4% |
| Handpiece break | 125 | 1.1% | 1% |
| Communication or transmission problemthe device could not communicate or transmit | 122 | 1% | 1.3% |
| Entrapment of device | 98 | 0.8% | 1% |
| Insufficient device problem information | 84 | 0.7% | 0.7% |
| Device slipped | 76 | 0.7% | 0.6% |
| Failure to advance | 76 | 0.7% | 0.6% |
| Breakthe device broke | 73 | 0.6% | 0.7% |
| Component falling | 69 | 0.6% | 0.6% |
| Unintended application program shut down | 62 | 0.5% | 0.5% |
| Difficult or delayed positioning | 52 | 0.4% | 0.5% |
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 | 737 | 6.3% |
| Airway obstruction | 436 | 3.7% |
| Hemorrhage/blood loss/bleeding | 93 | 0.8% |
| Aspiration/inhalation | 80 | 0.7% |
| Painpain, site not specified | 74 | 0.6% |
| Laceration(s) of esophagus | 65 | 0.6% |
| Chest painchest pain | 56 | 0.5% |
| Radiation exposure, unintended | 53 | 0.5% |
| Injurya physical injury | 43 | 0.4% |
| No patient involvement | 36 | 0.3% |
| Surgical procedure aborted/stopped | 31 | 0.3% |
| Therapy/non-surgical treatment, additional | 31 | 0.3% |
| Bleeding | 30 | 0.3% |
| Sedationdrowsiness from a medicine | 29 | 0.2% |
| Discomfortdiscomfort | 28 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Bravo | Product code FFT | All MAUDE reports |
|---|---|---|---|
| Reports | 11,648 | 12,898 | 26,136,888 |
| Share of that pool | — | 90.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 6.7% | 7.5% | 36.2% |
| Classified as malfunction | 93.1% | 92% | 62.3% |
| Filed by the manufacturer | 98.5% | 95.8% | 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 FFT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Bravo Ph Capsule Delivery Device | 372 | 0 | 0.3% |
| Bravo Ph Capsule Deliv Dev 1-Pk | 155 | 0 | 0.6% |
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 Bravo reports
How many FDA reports name Bravo?
11,648 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 568 in the latest 12 months.
What kinds of events are reported?
malfunction (93.1%), injury (6.7%) and other (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to adhere or bond (44.9%), positioning failure (30%), loss of or failure to bond (6.9%), other (for use when an appropriate device code cannot be identified) (5.2%) and separation failure (5.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.5%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Bravo 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.