Device brand name · Stapler 60 reload blue
SureForm: medical device reports filed with FDA
2,927 reports name it, 2018–2026. Manufacturer given most often on reports: Intuitive Surgical. Product code GDW.
- 2,927
- device reports naming the brand
- 0% of all MAUDE reports · about 378 a year
- 654
- reports, 12 months to August 2026
- 639 in the 12 months before
- 42.6%
- classified as malfunction
- 80.3% across the product code
- 1.2%
- classified as death, as reported
- 35 reports · not verified by FDA
2,927 medical device reports received by FDA name the brand "SureForm" (stapler 60 reload blue); the manufacturer given most often on reports is Intuitive Surgical; received from October 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
654 reports arrived in the 12 months to August 2026, close to the 639 of 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 (55.9%), malfunction (42.6%) and death (1.2%); 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 failure to form staple (21.4%), firing problem (21.4%) and difficult to open or close (12.3%). The patient problems coded most often are hemorrhage/blood loss/bleeding, foreign body in patient and failure to anastomose. 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 |
|---|---|---|---|
| Failure to form staple | 627 | 21.4% | 20.5% |
| Firing problem | 627 | 21.4% | 1.6% |
| Difficult to open or close | 360 | 12.3% | 9.7% |
| Failure to fire | 255 | 8.7% | 30% |
| Failure to cut | 145 | 5% | 2.4% |
| Detachment of device or device componentpart of the device came off | 133 | 4.5% | 2.4% |
| Unintended system motionthe device moved when it should not have | 133 | 4.5% | 0.2% |
| Misfire | 132 | 4.5% | 9.1% |
| Insufficient device problem information | 121 | 4.1% | 2.9% |
| Breakthe device broke | 74 | 2.5% | 4.9% |
| Material fragmentation | 73 | 2.5% | 0.1% |
| Difficult to removethe device was hard to remove | 55 | 1.9% | 1.7% |
| No device output | 54 | 1.8% | 0% |
| Unintended movement | 41 | 1.4% | 0.3% |
| Entrapment of device | 33 | 1.1% | 3.2% |
| Failure to sense | 29 | 1% | 0.1% |
| Defective devicethe device was defective | 28 | 1% | 0.2% |
| Activation problem | 11 | 0.4% | 0.3% |
| Patient device interaction problem | 11 | 0.4% | 0.7% |
| Positioning problem | 11 | 0.4% | 0.3% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 529 | 18.1% |
| Foreign body in patientpart of a device left in the patient | 115 | 3.9% |
| Failure to anastomose | 79 | 2.7% |
| Injurya physical injury | 32 | 1.1% |
| Blood loss | 25 | 0.9% |
| Hematomaa collection of blood under the skin or in tissue | 23 | 0.8% |
| Sepsisa severe body-wide response to infection | 23 | 0.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 14 | 0.5% |
| Device embedded in tissue or plaque | 9 | 0.3% |
| Tissue breakdown | 9 | 0.3% |
| Bowel perforation | 7 | 0.2% |
| Fistula | 7 | 0.2% |
| Painpain, site not specified | 7 | 0.2% |
| Perforation of vessels | 7 | 0.2% |
| Rectal anastomotic leakage | 7 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | SureForm | Product code GDW | All MAUDE reports |
|---|---|---|---|
| Reports | 2,927 | 170,752 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 12 | 6 | 9 |
| Classified as injury | 55.9% | 18.7% | 36.2% |
| Classified as malfunction | 42.6% | 80.3% | 62.3% |
| Filed by the manufacturer | 92.9% | 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% |
| 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% |
| Unknown Endo GIA Instrument | 1,512 | 33 | 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 SureForm reports
How many FDA reports name SureForm?
2,927 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 654 in the latest 12 months.
What kinds of events are reported?
injury (55.9%), malfunction (42.6%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to form staple (21.4%), firing problem (21.4%), difficult to open or close (12.3%), failure to fire (8.7%) and failure to cut (5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (92.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that SureForm 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.