Device brand name · Disposable surgical access device
Protack 5mm Instrument: medical device reports filed with FDA
309 reports name it, 2002–2016. Manufacturer given most often on reports: Ponce - Uss. Product code GDW.
- 309
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 32.7%
- classified as malfunction
- 80.3% across the product code
- 1.6%
- classified as death, as reported
- 5 reports · not verified by FDA
FDA's MAUDE database holds 309 reports that name the brand "Protack 5mm Instrument" (disposable surgical access device), received between January 2002 and November 2016; the manufacturer given most often on reports is Ponce - Uss. 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 other (46.3%), malfunction (32.7%) and injury (19.4%); 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 nonstandard device (57.3%), positioning failure (25.6%) and failure to fire (18.4%). The patient problems coded most often are tissue damage, bowel perforation and abdominal pain. 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
No report naming Protack 5mm Instrument was received in the five years to August 2026; the latest was received in November 2016.
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 |
|---|---|---|---|
| Nonstandard device | 177 | 57.3% | 0.2% |
| Positioning failure | 79 | 25.6% | 1.1% |
| Failure to fire | 57 | 18.4% | 30% |
| Mechanical jam | 56 | 18.1% | 2.3% |
| Sticking | 49 | 15.9% | 1.2% |
| Mechanical problema mechanical problem | 25 | 8.1% | 1.1% |
| Device inoperablethe device could not be used | 20 | 6.5% | 0.5% |
| Misfire | 20 | 6.5% | 9.1% |
| Difficult to open or close | 7 | 2.3% | 9.7% |
| Insufficient device problem information | 7 | 2.3% | 2.9% |
| Breakthe device broke | 5 | 1.6% | 4.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 1.6% | 2.3% |
| Device slipped | 4 | 1.3% | 0.4% |
| Component falling | 3 | 1% | 0.5% |
| Difficult to removethe device was hard to remove | 3 | 1% | 1.7% |
| Out-of-box failure | 3 | 1% | 0% |
| Activation, positioning or separation problem | 2 | 0.6% | 0.2% |
| Crackthe device cracked | 2 | 0.6% | 0.1% |
| Detachment of device component | 2 | 0.6% | 1.2% |
| Difficult or delayed positioning | 2 | 0.6% | 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 |
|---|---|---|
| Tissue damage | 5 | 1.6% |
| Bowel perforation | 4 | 1.3% |
| Abdominal painstomach or belly pain | 3 | 1% |
| Injurya physical injury | 3 | 1% |
| Device embedded in tissue or plaque | 2 | 0.6% |
| Painpain, site not specified | 2 | 0.6% |
| Perforation | 2 | 0.6% |
| Cardiac tamponade | 1 | 0.3% |
| Exposure to body fluids | 1 | 0.3% |
| Fever | 1 | 0.3% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.3% |
| Hemorrhage/blood loss/bleeding | 1 | 0.3% |
| Hernia | 1 | 0.3% |
| Inflammationinflammation | 1 | 0.3% |
| Nauseafeeling sick | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Protack 5mm Instrument | Product code GDW | All MAUDE reports |
|---|---|---|---|
| Reports | 309 | 170,752 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 16 | 6 | 9 |
| Classified as injury | 19.4% | 18.7% | 36.2% |
| Classified as malfunction | 32.7% | 80.3% | 62.3% |
| Filed by the manufacturer | 100% | 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 Protack 5mm Instrument reports
How many FDA reports name Protack 5mm Instrument?
309 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?
other (46.3%), malfunction (32.7%) and injury (19.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
nonstandard device (57.3%), positioning failure (25.6%), failure to fire (18.4%), mechanical jam (18.1%) and sticking (15.9%). 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 Protack 5mm Instrument 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.