Devices › Apparatus, suction, single patient use, portable, nonpowered
Device brand name · Wound drainage system
J-VAC Reservoir: medical device reports filed with FDA
719 reports name it, 1997–2026. Manufacturer given most often on reports: Ethicon. Product code GCY.
- 719
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 16
- reports, 12 months to August 2026
- 0 in the 12 months before
- 86.1%
- classified as malfunction
- 61% across the product code
- 0.4%
- classified as death, as reported
- 3 reports · not verified by FDA
719 medical device reports received by FDA name the brand "J-VAC Reservoir" (wound drainage system); the manufacturer given most often on reports is Ethicon; received from December 1997 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
16 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 (86.1%), injury (13.4%) and death (0.4%); across all apparatus, suction, single patient use, portable, nonpowered reports (product code GCY) death is recorded in 0.3% and malfunction in 61%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are tears, rips, holes in device, device material (18.8%), air leak (16.7%) and valve(s), failure of (13.9%). The patient problems coded most often are surgical procedure, treatment with medication(s) and fever. 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 4,711 reports carrying product code GCY. 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 |
|---|---|---|---|
| Tears, rips, holes in device, device material | 135 | 18.8% | 4.7% |
| Air leak | 120 | 16.7% | 3.7% |
| Valve(s), failure of | 100 | 13.9% | 0.9% |
| Other (for use when an appropriate device code cannot be identified) | 92 | 12.8% | 3.7% |
| Locking mechanism failure | 84 | 11.7% | 1.3% |
| Replace | 77 | 10.7% | 3.2% |
| Decrease in suction | 39 | 5.4% | 0.9% |
| Material separation | 28 | 3.9% | 3.5% |
| Device issuea problem with the device | 22 | 3.1% | 1.2% |
| Obstruction of flow | 15 | 2.1% | 0.1% |
| Device, removal of (non-implant) | 12 | 1.7% | 3.2% |
| Leak/splashthe device leaked | 12 | 1.7% | 1.4% |
| Detachment of device component | 8 | 1.1% | 4.4% |
| Suction problem | 8 | 1.1% | 5.6% |
| Disconnection | 7 | 1% | 6.3% |
| Explanted | 7 | 1% | 5% |
| No device output | 7 | 1% | 0.1% |
| Output, low | 5 | 0.7% | 0.2% |
| Inflation problem | 4 | 0.6% | 2.5% |
| Torn material | 4 | 0.6% | 0.2% |
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 |
|---|---|---|
| Surgical procedure | 39 | 5.4% |
| Treatment with medication(s) | 29 | 4% |
| Fever | 22 | 3.1% |
| Hematomaa collection of blood under the skin or in tissue | 19 | 2.6% |
| Post operative wound infection | 19 | 2.6% |
| Therapy/non-surgical treatment, additional | 14 | 1.9% |
| Inflammationinflammation | 12 | 1.7% |
| Surgical procedure, additional | 10 | 1.4% |
| Surgical procedure, repeated | 8 | 1.1% |
| Staphylococcus aureus | 6 | 0.8% |
| Erythemaskin redness | 5 | 0.7% |
| Bleeding | 4 | 0.6% |
| Deaththe patient died; cause not stated by this term | 4 | 0.6% |
| Hospitalization required | 4 | 0.6% |
| Other (for use when an appropriate patient code cannot be identified) | 4 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | J-VAC Reservoir | Product code GCY | All MAUDE reports |
|---|---|---|---|
| Reports | 719 | 4,711 | 26,136,888 |
| Share of that pool | — | 15.3% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 13.4% | 34.1% | 36.2% |
| Classified as malfunction | 86.1% | 61% | 62.3% |
| Filed by the manufacturer | 100% | 76.5% | 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 GCY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| BLAKE Drain | 738 | 4 | 1.8% |
| Closed Wound Suction | 286 | 80 | 0% |
| Cws 400 Closed Wound Suction Kit Pvc Drain | 175 | 0 | 0% |
| Ivt Disposable | 4,238 | 0 | 0% |
| Baxter | 821 | 3 | 3.8% |
| Zimmer | 1,159 | 0 | 2.8% |
| Tbd | 622 | 8 | 0.6% |
| Argyle | 871 | 60 | 1% |
| Endo Gia Universal Xl | 165 | 0 | 1.8% |
| Ni | 32,939 | 1,587 | 1.8% |
| Bard | 1,124 | 2 | 1.8% |
| Cardinal Health | 589 | 185 | 0.2% |
| Endopouch Retriever Spec Bag | 734 | 35 | 0% |
| Medline | 26,935 | 26,184 | 0.1% |
| Stryker | 559 | 5 | 1.3% |
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 J-VAC Reservoir reports
How many FDA reports name J-VAC Reservoir?
719 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 16 in the latest 12 months.
What kinds of events are reported?
malfunction (86.1%), injury (13.4%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
tears, rips, holes in device, device material (18.8%), air leak (16.7%), valve(s), failure of (13.9%), other (for use when an appropriate device code cannot be identified) (12.8%) and locking mechanism failure (11.7%). 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 J-VAC Reservoir 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.