Device brand name · Staple removable skin
Visistat 35r 6/Box: medical device reports filed with FDA
1,091 reports name it, 2013–2025. Manufacturer given most often on reports: Teleflex Medical. Product code QQS.
- 1,091
- device reports naming the brand
- 0% of all MAUDE reports · about 83 a year
- 0
- reports, 12 months to August 2026
- 4 in the 12 months before
- 100%
- classified as malfunction
- 99.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
1,091 medical device reports received by FDA name the brand "Visistat 35r 6/Box" (staple removable skin); the manufacturer given most often on reports is Teleflex Medical; received from May 2013 to May 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 4 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 (100%); across all stapler, skin reports (product code QQS) death is recorded in 0% and malfunction in 99.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are mechanical jam (69.5%), failure to form staple (11.5%) and misfire (4%). The patient problems coded most often are no patient involvement, pain and blood loss. 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 3,781 reports carrying product code QQS. 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 | 758 | 69.5% | 61.3% |
| Failure to form staple | 125 | 11.5% | 3.9% |
| Misfire | 44 | 4% | 2.1% |
| Failure to fire | 40 | 3.7% | 6.8% |
| Physical resistance/sticking | 25 | 2.3% | 2.6% |
| Failure to align | 19 | 1.7% | 5% |
| Delivered as unsterile product | 17 | 1.6% | 2.6% |
| Activation, positioning or separation problem | 14 | 1.3% | 0.1% |
| Failure to advance | 12 | 1.1% | 0% |
| Breakthe device broke | 11 | 1% | 0.2% |
| Improper or incorrect procedure or method | 9 | 0.8% | 0.3% |
| Difficult to open or close | 7 | 0.6% | 0.8% |
| Separation failure | 6 | 0.5% | 0.1% |
| Detachment of device or device componentpart of the device came off | 5 | 0.5% | 0.5% |
| Entrapment of device | 5 | 0.5% | 0% |
| Component missing | 4 | 0.4% | 0% |
| Material deformation | 4 | 0.4% | 0.2% |
| Insufficient device problem information | 3 | 0.3% | 0.3% |
| Material twisted/bent | 3 | 0.3% | 0.1% |
| Premature activation | 3 | 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 | 6 | 0.5% |
| Painpain, site not specified | 2 | 0.2% |
| Blood loss | 1 | 0.1% |
| Skin tears | 1 | 0.1% |
| Wound dehiscencea wound reopened | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Visistat 35r 6/Box | Product code QQS | All MAUDE reports |
|---|---|---|---|
| Reports | 1,091 | 3,781 | 26,136,888 |
| Share of that pool | — | 28.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0% | 0.6% | 36.2% |
| Classified as malfunction | 100% | 99.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 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 QQS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Weck Visistat Skin Stapler 35r | 1,273 | 26 | 0% |
| Weck Visistat Skin Stapler 35w | 695 | 49 | 0% |
| Weck Visistat 35r 6/Box | 453 | 47 | 0% |
| Visistat 35w 6/Box | 1,749 | 3 | 0% |
| Weck Visistat 35w 6/Box | 420 | 167 | 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 35r 6/Box reports
How many FDA reports name Visistat 35r 6/Box?
1,091 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?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical jam (69.5%), failure to form staple (11.5%), misfire (4%), failure to fire (3.7%) and physical resistance/sticking (2.3%). 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 35r 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.