Devices › Cannula, manipulator/injector, uterine
Device brand name · Cannula manipulator/injector uterine
Vcare: medical device reports filed with FDA
324 reports name it, 2008–2026. Manufacturer given most often on reports: Conmed. Product code LKF.
- 324
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 71
- reports, 12 months to August 2026
- 69 in the 12 months before
- 91.7%
- classified as malfunction
- 82.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
324 medical device reports received by FDA name the brand "Vcare" (cannula manipulator/injector uterine); the manufacturer given most often on reports is Conmed; received from March 2008 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
71 reports arrived in the 12 months to August 2026, close to the 69 of 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 (91.7%), injury (7.1%) and other (0.9%); across all cannula, manipulator/injector, uterine reports (product code LKF) death is recorded in 0.1% and malfunction in 82.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are detachment of device or device component (15.4%), inflation problem (9.6%) and break (9.3%). The patient problems coded most often are foreign body in patient, uterine perforation and 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
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 1,788 reports carrying product code LKF. 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 |
|---|---|---|---|
| Detachment of device or device componentpart of the device came off | 50 | 15.4% | 12.3% |
| Inflation problem | 31 | 9.6% | 6.6% |
| Breakthe device broke | 30 | 9.3% | 15.7% |
| Material fragmentation | 26 | 8% | 5.9% |
| Material separation | 16 | 4.9% | 6.5% |
| Failure to deflate | 15 | 4.6% | 1.6% |
| Leak/splashthe device leaked | 15 | 4.6% | 1% |
| Component(s), broken | 8 | 2.5% | 1.5% |
| Loose | 6 | 1.9% | 0.3% |
| Unintended movement | 6 | 1.9% | 5.1% |
| Deflation problem | 5 | 1.5% | 1.7% |
| Detachment of device component | 5 | 1.5% | 9.4% |
| Material puncture/hole | 5 | 1.5% | 0.9% |
| Gas/air leak | 4 | 1.2% | 0.3% |
| Improper or incorrect procedure or method | 4 | 1.2% | 1.5% |
| Unstable | 4 | 1.2% | 0.2% |
| Defective component | 3 | 0.9% | 0.4% |
| Dislodged | 3 | 0.9% | 0.2% |
| Fluid/blood leak | 3 | 0.9% | 0.8% |
| Insufficient device problem information | 3 | 0.9% | 1.2% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 11 | 3.4% |
| Uterine perforationa hole in the wall of the womb | 9 | 2.8% |
| Painpain, site not specified | 3 | 0.9% |
| Abdominal painstomach or belly pain | 2 | 0.6% |
| Device embedded in tissue or plaque | 2 | 0.6% |
| Foreign body, removal of | 2 | 0.6% |
| Nonresorbable materials, unretrieved in body | 2 | 0.6% |
| Abscessa collection of pus | 1 | 0.3% |
| Discomfortdiscomfort | 1 | 0.3% |
| Hemorrhage/blood loss/bleeding | 1 | 0.3% |
| Hospitalization required | 1 | 0.3% |
| Improved patient condition | 1 | 0.3% |
| Internal organ perforation | 1 | 0.3% |
| Laceration(s) | 1 | 0.3% |
| Obstruction/occlusion | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Vcare | Product code LKF | All MAUDE reports |
|---|---|---|---|
| Reports | 324 | 1,788 | 26,136,888 |
| Share of that pool | — | 18.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 7.1% | 13.9% | 36.2% |
| Classified as malfunction | 91.7% | 82.2% | 62.3% |
| Filed by the manufacturer | 52.8% | 68.1% | 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 LKF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Uterine Manipulator - 7cm | 192 | 0 | 0% |
| Vcare 200a - Medium | 163 | 0 | 0% |
| Cook Silicone Balloon Hysterosalpingography Injection Catheter | 169 | 0 | 0% |
| Conmed | 900 | 89 | 0.2% |
| Endopath | 435 | 74 | 1.4% |
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 Vcare reports
How many FDA reports name Vcare?
324 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 71 in the latest 12 months.
What kinds of events are reported?
malfunction (91.7%), injury (7.1%) and other (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
detachment of device or device component (15.4%), inflation problem (9.6%), break (9.3%), material fragmentation (8%) and material separation (4.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (52.8%) and voluntary reports (5.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Vcare 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.