Devices › Gauze/sponge, internal, x-ray detectable
Device brand name · Gauze/sponge internal x-ray detectable
Situate: medical device reports filed with FDA
735 reports name it, 2017–2026. Manufacturer given most often on reports: Mitg - Rf Surgical Systems. Product code GDY.
- 735
- device reports naming the brand
- 0% of all MAUDE reports · about 84 a year
- 50
- reports, 12 months to August 2026
- 44 in the 12 months before
- 90.1%
- classified as malfunction
- 86.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
735 medical device reports received by FDA name the brand "Situate" (gauze/sponge internal x-ray detectable); the manufacturer given most often on reports is Mitg - Rf Surgical Systems; received from October 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
50 reports arrived in the 12 months to August 2026, up 14% from 44 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 (90.1%) and injury (9.9%); across all gauze/sponge, internal, x-ray detectable reports (product code GDY) death is recorded in 0.1% and malfunction in 86.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are false positive result (30.6%), detachment of device or device component (28.4%) and material fragmentation (27.6%). The patient problems coded most often are no patient involvement, unintended radiation exposure and foreign body in patient. 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 2,528 reports carrying product code GDY. 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 |
|---|---|---|---|
| False positive result | 225 | 30.6% | 0% |
| Detachment of device or device componentpart of the device came off | 209 | 28.4% | 10% |
| Material fragmentation | 203 | 27.6% | 15.6% |
| False negative result | 99 | 13.5% | 0.3% |
| Material frayed | 29 | 3.9% | 22.3% |
| Device displays incorrect message | 13 | 1.8% | 0% |
| Particulates | 6 | 0.8% | 2.2% |
| Insufficient device problem information | 5 | 0.7% | 0.2% |
| Component missing | 4 | 0.5% | 4.8% |
| Contamination | 4 | 0.5% | 0.9% |
| Breakthe device broke | 3 | 0.4% | 1.6% |
| Defective devicethe device was defective | 3 | 0.4% | 0.3% |
| Detachment of device component | 3 | 0.4% | 3.2% |
| Device misassembled during manufacturing /shipping | 3 | 0.4% | 0.8% |
| No display/image | 3 | 0.4% | 0% |
| Electromagnetic compatibility problem | 2 | 0.3% | 0% |
| Failure to power up | 2 | 0.3% | 0% |
| Fire | 2 | 0.3% | 0.1% |
| Loose or intermittent connection | 2 | 0.3% | 0.3% |
| Material deformation | 2 | 0.3% | 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 |
|---|---|---|
| No patient involvement | 64 | 8.7% |
| Unintended radiation exposure | 34 | 4.6% |
| Foreign body in patientpart of a device left in the patient | 28 | 3.8% |
| Radiation exposure, unintended | 14 | 1.9% |
| Device embedded in tissue or plaque | 10 | 1.4% |
| Tissue breakdown | 4 | 0.5% |
| Hemorrhage/blood loss/bleeding | 2 | 0.3% |
| Abnormal vaginal discharge | 1 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.1% |
| Burn, thermal | 1 | 0.1% |
| Foreign body reaction | 1 | 0.1% |
| Injurya physical injury | 1 | 0.1% |
| Painpain, site not specified | 1 | 0.1% |
| Skin tears | 1 | 0.1% |
| Tissue damage | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Situate | Product code GDY | All MAUDE reports |
|---|---|---|---|
| Reports | 735 | 2,528 | 26,136,888 |
| Share of that pool | — | 29.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 9.9% | 8.1% | 36.2% |
| Classified as malfunction | 90.1% | 86.7% | 62.3% |
| Filed by the manufacturer | 97.4% | 80.5% | 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 GDY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Vistec | 289 | 29 | 0% |
| Unknown Instruments Product | 400 | 23 | 0.8% |
| Medline | 26,935 | 26,184 | 0.1% |
| Curity | 664 | 18 | 0.2% |
| Covidien | 422 | 30 | 1.4% |
| Deroyal | 587 | 14 | 0.7% |
| Kendall | 213 | 23 | 2.3% |
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 Situate reports
How many FDA reports name Situate?
735 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 50 in the latest 12 months.
What kinds of events are reported?
malfunction (90.1%) and injury (9.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
false positive result (30.6%), detachment of device or device component (28.4%), material fragmentation (27.6%), false negative result (13.5%) and material frayed (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.4%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Situate 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.