Device brand name · Staple implantable
Optifix Straight: medical device reports filed with FDA
268 reports name it, 2020–2026. Manufacturer given most often on reports: Davol Sub C R Bard -1213643. Product code GDW.
- 268
- device reports naming the brand
- 0% of all MAUDE reports · about 45 a year
- 35
- reports, 12 months to August 2026
- 28 in the 12 months before
- 97%
- classified as malfunction
- 80.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 268 reports that name the brand "Optifix Straight" (staple implantable), received between July 2020 and August 2026; the manufacturer given most often on reports is Davol Sub C R Bard -1213643. Spellings of one product vary from report to report.
35 reports arrived in the 12 months to August 2026, up 25% from 28 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 (97%) and injury (3%); across all staple, implantable reports (product code GDW) death is recorded in 0.6% and malfunction in 80.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (54.9%), failure to form staple (43.3%) and detachment of device or device component (6.7%). The patient problems coded most often are foreign body in patient, abdominal pain 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 170,752 reports carrying product code GDW. 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 | 147 | 54.9% | 4.9% |
| Failure to form staple | 116 | 43.3% | 20.5% |
| Detachment of device or device componentpart of the device came off | 18 | 6.7% | 2.4% |
| Failure to fire | 11 | 4.1% | 30% |
| Unintended ejection | 9 | 3.4% | 0.3% |
| Material twisted/bent | 8 | 3% | 0.3% |
| Ambient temperature problem | 4 | 1.5% | 0% |
| Patient-device incompatibilitythe device did not suit the patient | 4 | 1.5% | 0.1% |
| Expiration date error | 2 | 0.7% | 0% |
| Mechanical jam | 2 | 0.7% | 2.3% |
| Component missing | 1 | 0.4% | 0.3% |
| Device contamination with chemical or other material | 1 | 0.4% | 0.1% |
| Failure to align | 1 | 0.4% | 0.3% |
| Improper or incorrect procedure or method | 1 | 0.4% | 0.1% |
| Incorrect, inadequate or imprecise result or readings | 1 | 0.4% | 0% |
| Misfire | 1 | 0.4% | 9.1% |
| Patient device interaction problem | 1 | 0.4% | 0.7% |
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 | 7 | 2.6% |
| Abdominal painstomach or belly pain | 2 | 0.7% |
| Device embedded in tissue or plaque | 2 | 0.7% |
| Painpain, site not specified | 2 | 0.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.4% |
| Depressionlow mood | 1 | 0.4% |
| Fatiguetiredness | 1 | 0.4% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.4% |
| Hemorrhage/blood loss/bleeding | 1 | 0.4% |
| Hernia | 1 | 0.4% |
| Reactiona reaction, type not specified | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Optifix Straight | Product code GDW | All MAUDE reports |
|---|---|---|---|
| Reports | 268 | 170,752 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 3% | 18.7% | 36.2% |
| Classified as malfunction | 97% | 80.3% | 62.3% |
| Filed by the manufacturer | 99.6% | 97% | 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 GDW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endo GIA | 30,619 | 2,086 | 0.3% |
| Endo GIA Ultra | 17,281 | 1,116 | 0.1% |
| Signia | 9,434 | 1,130 | 0.1% |
| Tri-Staple 2.0 | 5,267 | 661 | 0.3% |
| Gia | 4,899 | 404 | 0.9% |
| Eea | 4,922 | 542 | 0.8% |
| Powered 60 Echelon + 340mm Shaft | 3,237 | 224 | 0.4% |
| Ets Flex Articng Lnr Cutr 45mm | 2,512 | 79 | 0.3% |
| Unknown Endo GIA SULU | 2,408 | 205 | 1.9% |
| SureForm | 2,927 | 654 | 1.2% |
| Contour Curved Cutter Stapler | 1,961 | 11 | 0.3% |
| Ils 29mm Curved | 1,945 | 48 | 0.9% |
| Powered 60 Echelon + 440mm Shaft | 1,775 | 49 | 0.4% |
| Echelon Flex Powered Vascular Stapler With Advanced Placement Tip | 1,770 | 180 | 1.6% |
| 75mm Selectable New Tlc | 1,603 | 57 | 1.1% |
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 Optifix Straight reports
How many FDA reports name Optifix Straight?
268 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 35 in the latest 12 months.
What kinds of events are reported?
malfunction (97%) and injury (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (54.9%), failure to form staple (43.3%), detachment of device or device component (6.7%), failure to fire (4.1%) and unintended ejection (3.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Optifix Straight 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.