Devices › Laryngoscope, endoscope
Device brand name · Single use specimen retrieval product
Endo Catch Gold 10mm Specimen Pouch Intl: medical device reports filed with FDA
491 reports name it, 2004–2017. Manufacturer given most often on reports: Covidien. Product code GCI.
- 491
- device reports naming the brand
- 0% of all MAUDE reports · about 22 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 93.1%
- classified as malfunction
- 92.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 491 reports that name the brand "Endo Catch Gold 10mm Specimen Pouch Intl" (single use specimen retrieval product), received between January 2004 and February 2017; the manufacturer given most often on reports is Covidien. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and 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 (93.1%) and injury (6.5%); across all laryngoscope, endoscope reports (product code GCI) death is recorded in 0.2% and malfunction in 92.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (33%), torn material (19.8%) and component falling (12.4%). The patient problems coded most often are foreign body, removal of, hemorrhage/blood loss/bleeding and tissue damage. 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
No report naming Endo Catch Gold 10mm Specimen Pouch Intl was received in the five years to August 2026; the latest was received in February 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,682 reports carrying product code GCI. 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 | 162 | 33% | 17.1% |
| Torn material | 97 | 19.8% | 14.7% |
| Component falling | 61 | 12.4% | 2.3% |
| Detachment of device component | 52 | 10.6% | 5.5% |
| Detachment of device or device componentpart of the device came off | 30 | 6.1% | 12.7% |
| Replace | 26 | 5.3% | 0% |
| Component(s), broken | 21 | 4.3% | 0% |
| Material separation | 21 | 4.3% | 7.5% |
| Device, removal of (non-implant) | 13 | 2.6% | 0% |
| Difficult to removethe device was hard to remove | 13 | 2.6% | 1.4% |
| Material integrity problema problem with the device material | 13 | 2.6% | 0.5% |
| Split | 13 | 2.6% | 0.6% |
| Hole in material | 12 | 2.4% | 0.5% |
| Tears, rips, holes in device, device material | 11 | 2.2% | 0.1% |
| Burst container or vessel | 8 | 1.6% | 0.4% |
| Difficult to open or close | 8 | 1.6% | 0.7% |
| Sticking | 8 | 1.6% | 0% |
| Disengaged | 6 | 1.2% | 0% |
| Material rupture | 6 | 1.2% | 1.4% |
| Device contamination with chemical or other material | 5 | 1% | 0.5% |
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, removal of | 24 | 4.9% |
| Hemorrhage/blood loss/bleeding | 19 | 3.9% |
| Tissue damage | 17 | 3.5% |
| Foreign body in patientpart of a device left in the patient | 12 | 2.4% |
| Blood loss | 6 | 1.2% |
| Device embedded in tissue or plaque | 5 | 1% |
| No patient involvement | 5 | 1% |
| Complaint, ill-defined | 3 | 0.6% |
| Laparotomy | 3 | 0.6% |
| Nonresorbable materials, unretrieved in body | 3 | 0.6% |
| Abdominal painstomach or belly pain | 2 | 0.4% |
| Injurya physical injury | 2 | 0.4% |
| Surgical procedure | 2 | 0.4% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
| Elevated ketones/ diabetic ketoacidosis | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endo Catch Gold 10mm Specimen Pouch Intl | Product code GCI | All MAUDE reports |
|---|---|---|---|
| Reports | 491 | 1,682 | 26,136,888 |
| Share of that pool | — | 29.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 6.5% | 6.8% | 36.2% |
| Classified as malfunction | 93.1% | 92.4% | 62.3% |
| Filed by the manufacturer | 100% | 92.6% | 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 GCI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Endo Catch Gold | 782 | 83 | 0% |
| 7mm Extended Length Endoscope | 317 | 30 | 0% |
| Bom 7mm Extended Length Endoscope | 210 | 0 | 0% |
| Camera Head Lens Int Sys | 206 | 0 | 0% |
| TruClear | 481 | 58 | 0.6% |
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 Endo Catch Gold 10mm Specimen Pouch Intl reports
How many FDA reports name Endo Catch Gold 10mm Specimen Pouch Intl?
491 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 (93.1%) and injury (6.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (33%), torn material (19.8%), component falling (12.4%), detachment of device component (10.6%) and detachment of device or device component (6.1%). 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 Endo Catch Gold 10mm Specimen Pouch Intl 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.