Devices › Suture, absorbable, synthetic, polyglycolic acid
Device brand name · Suture absorbable synthetic
Vcl+ Vio 36in 2-0 S/A Ct-1: medical device reports filed with FDA
399 reports name it, 2019–2026. Manufacturer given most often on reports: Ethicon. Product code GAM.
- 399
- device reports naming the brand
- 0% of all MAUDE reports · about 56 a year
- 42
- reports, 12 months to August 2026
- 69 in the 12 months before
- 86.2%
- classified as malfunction
- 76.5% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
399 medical device reports received by FDA name the brand "Vcl+ Vio 36in 2-0 S/A Ct-1" (suture absorbable synthetic); the manufacturer given most often on reports is Ethicon; received from June 2019 to March 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
42 reports arrived in the 12 months to August 2026, down 39% from 69 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 (86.2%), injury (13.5%) and death (0.3%); across all suture, absorbable, synthetic, polyglycolic acid reports (product code GAM) death is recorded in 0.2% and malfunction in 76.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (57.1%), material separation (21.3%) and material integrity problem (6.8%). The patient problems coded most often are impaired healing, pain and inflammation. 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 56,946 reports carrying product code GAM. 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 | 228 | 57.1% | 36.3% |
| Material separation | 85 | 21.3% | 18.8% |
| Material integrity problema problem with the device material | 27 | 6.8% | 1.6% |
| Component missing | 13 | 3.3% | 0.6% |
| Tear, rip or hole in device packaging | 6 | 1.5% | 0.3% |
| Defective component | 4 | 1% | 0.4% |
| Component incompatible | 3 | 0.8% | 0.1% |
| Device contaminated during manufacture or shipping | 3 | 0.8% | 0.4% |
| Device markings/labelling problema problem with the device markings or label | 2 | 0.5% | 0.6% |
| Material frayed | 2 | 0.5% | 1.2% |
| Component misassembled | 1 | 0.3% | 0.3% |
| Fracturea broken bone | 1 | 0.3% | 0.1% |
| Material deformation | 1 | 0.3% | 0.1% |
| Material protrusion/extrusion | 1 | 0.3% | 0% |
| Positioning failure | 1 | 0.3% | 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 |
|---|---|---|
| Impaired healingslow healing | 31 | 7.8% |
| Painpain, site not specified | 21 | 5.3% |
| Inflammationinflammation | 20 | 5% |
| Fluid discharge | 16 | 4% |
| Wound dehiscencea wound reopened | 14 | 3.5% |
| Erythemaskin redness | 10 | 2.5% |
| Not applicable | 9 | 2.3% |
| Purulent discharge | 8 | 2% |
| Swelling/ edema | 7 | 1.8% |
| Hemorrhage/blood loss/bleeding | 6 | 1.5% |
| Pocket erosion | 5 | 1.3% |
| Post operative wound infection | 5 | 1.3% |
| Discomfortdiscomfort | 4 | 1% |
| Foreign body in patientpart of a device left in the patient | 4 | 1% |
| Local reaction | 4 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Vcl+ Vio 36in 2-0 S/A Ct-1 | Product code GAM | All MAUDE reports |
|---|---|---|---|
| Reports | 399 | 56,946 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 3 | 2 | 9 |
| Classified as injury | 13.5% | 23% | 36.2% |
| Classified as malfunction | 86.2% | 76.5% | 62.3% |
| Filed by the manufacturer | 100% | 98% | 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 GAM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Polysorb | 5,410 | 1,836 | 0% |
| V-Loc 180 | 3,447 | 678 | 0% |
| Vicryl Polyglactin 910 Suture Unknown Product | 2,373 | 210 | 1.2% |
| Coated VICRYL (polyglactin 910) Suture | 1,930 | 20 | 0.5% |
| Maxon | 1,809 | 309 | 0% |
| Biosyn | 1,681 | 261 | 0% |
| V-Loc 90 | 1,378 | 226 | 0% |
| VICRYL Polyglactin 910 Suture | 1,262 | 74 | 0.1% |
| Vcl+ Ud 27in 5-0 S/A Tf | 1,125 | 158 | 0.1% |
| Coated VICRYL | 978 | 851 | 0% |
| Vicryl Plus Antibacterial Polyglactin 910 Suture | 852 | 0 | 0.1% |
| Coated Vicryl Plus Antibacterial Polyglactin 910 | 724 | 0 | 0% |
| Vcl+ Ud 18in 5-0 S/A P-3 Prm Mp | 518 | 126 | 0% |
| Unknown VLoc Product | 413 | 39 | 3.6% |
| Caprosyn | 399 | 94 | 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 Vcl+ Vio 36in 2-0 S/A Ct-1 reports
How many FDA reports name Vcl+ Vio 36in 2-0 S/A Ct-1?
399 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 42 in the latest 12 months.
What kinds of events are reported?
malfunction (86.2%), injury (13.5%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (57.1%), material separation (21.3%), material integrity problem (6.8%), component missing (3.3%) and tear, rip or hole in device packaging (1.5%). 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 Vcl+ Vio 36in 2-0 S/A Ct-1 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.