Devices › Staple, removable (skin)
Device brand name · Staple removable skin
Visistat 35w 6/Box: medical device reports filed with FDA
1,749 reports name it, 2013–2026. Manufacturer given most often on reports: Teleflex Medical. Product code GDT.
- 1,749
- device reports naming the brand
- 0% of all MAUDE reports · about 132 a year
- 3
- reports, 12 months to August 2026
- 0 in the 12 months before
- 99.3%
- classified as malfunction
- 93.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,749 reports that name the brand "Visistat 35w 6/Box" (staple removable skin), received between April 2013 and July 2026; the manufacturer given most often on reports is Teleflex Medical. Spellings of one product vary from report to report.
3 reports arrived in the 12 months to August 2026, with 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 malfunction (99.3%) and injury (0.7%); across all staple, removable (skin) reports (product code GDT) death is recorded in 0% and malfunction in 93.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are mechanical jam (53.2%), failure to form staple (13.3%) and device damaged prior to receipt by user (7%). The patient problems coded most often are no patient involvement, not applicable and wound dehiscence. 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 4,748 reports carrying product code GDT. 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 |
|---|---|---|---|
| Mechanical jam | 930 | 53.2% | 30.5% |
| Failure to form staple | 233 | 13.3% | 28.5% |
| Device damaged prior to receipt by user | 122 | 7% | 0.1% |
| Tear, rip or hole in device packaging | 114 | 6.5% | 1.6% |
| Delivered as unsterile product | 90 | 5.1% | 1% |
| Difficult to open or close | 62 | 3.5% | 1.9% |
| Misfire | 56 | 3.2% | 4.4% |
| Activation, positioning or separation problem | 53 | 3% | 1.3% |
| Unsealed device packaging | 42 | 2.4% | 0.9% |
| Failure to align | 39 | 2.2% | 0.5% |
| Loss of or failure to bond | 29 | 1.7% | 0.6% |
| Premature activation | 21 | 1.2% | 0.5% |
| Detachment of device or device componentpart of the device came off | 16 | 0.9% | 0.8% |
| Loose or intermittent connection | 11 | 0.6% | 0.4% |
| Physical resistance/sticking | 10 | 0.6% | 0.1% |
| Unintended movement | 10 | 0.6% | 0.2% |
| Entrapment of device | 8 | 0.5% | 1.6% |
| Difficult or delayed positioning | 7 | 0.4% | 0.3% |
| Failure to fire | 6 | 0.3% | 2.5% |
| Packaging problem | 6 | 0.3% | 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 |
|---|---|---|
| No patient involvement | 113 | 6.5% |
| Not applicable | 21 | 1.2% |
| Wound dehiscencea wound reopened | 10 | 0.6% |
| Impaired healingslow healing | 6 | 0.3% |
| Skin disorders | 4 | 0.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.1% |
| Painpain, site not specified | 2 | 0.1% |
| Abscessa collection of pus | 1 | 0.1% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.1% |
| Rashskin rash | 1 | 0.1% |
| Scar tissue | 1 | 0.1% |
| Skin irritationirritated skin | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Visistat 35w 6/Box | Product code GDT | All MAUDE reports |
|---|---|---|---|
| Reports | 1,749 | 4,748 | 26,136,888 |
| Share of that pool | — | 36.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.7% | 5.5% | 36.2% |
| Classified as malfunction | 99.3% | 93.7% | 62.3% |
| Filed by the manufacturer | 100% | 95.2% | 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 GDT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Visistat 35r 6/Box | 1,091 | 0 | 0% |
| Proximate Skin Stapler 35 Wide | 239 | 0 | 0% |
| Appose Ulc | 156 | 27 | 0% |
| Visistat Skin Stapler 35w | 155 | 0 | 0% |
| Weck Visistat 35w 6/Box | 420 | 167 | 0% |
| Weck Visistat 35r 6/Box | 453 | 47 | 0% |
| Proximate | 386 | 102 | 1% |
| Auto Suture | 3,100 | 234 | 0.1% |
| Weck Visistat Skin Stapler 35w | 695 | 49 | 0% |
| Egia 60 Articulating Med/Thick Sulu | 489 | 0 | 1.2% |
| Conmed | 900 | 89 | 0.2% |
| Egia Ultra Universal Stapler | 422 | 0 | 2.8% |
| Hemolok Ml Clips 6/Cart 84/Box | 540 | 0 | 0.2% |
| Weck Visistat Skin Stapler 35r | 1,273 | 26 | 0% |
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 Visistat 35w 6/Box reports
How many FDA reports name Visistat 35w 6/Box?
1,749 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 (99.3%) and injury (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical jam (53.2%), failure to form staple (13.3%), device damaged prior to receipt by user (7%), tear, rip or hole in device packaging (6.5%) and delivered as unsterile product (5.1%). 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 Visistat 35w 6/Box 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.