Devices › Forceps, biopsy, non-electric
Device brand name · Forceps biopsy non-electric
Radial Jaw 4 Biopsy Forceps: medical device reports filed with FDA
399 reports name it, 2008–2011. Manufacturer given most often on reports: Boston Scientific - Costa Rica. Product code FCL.
- 399
- 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
- 71.2%
- classified as malfunction
- 72.3% across the product code
- 1%
- classified as death, as reported
- 4 reports · not verified by FDA
399 medical device reports received by FDA name the brand "Radial Jaw 4 Biopsy Forceps" (forceps biopsy non-electric); the manufacturer given most often on reports is Boston Scientific - Costa Rica; received from June 2008 to November 2011. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (71.2%), injury (27.8%) and death (1%); across all forceps, biopsy, non-electric reports (product code FCL) death is recorded in 0.6% and malfunction in 72.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are bent (19.3%), break (12%) and insufficient device problem information (3.5%). The patient problems coded most often are blood loss, hemorrhage/blood loss/bleeding and bleeding. 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 Radial Jaw 4 Biopsy Forceps was received in the five years to August 2026; the latest was received in November 2011.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,711 reports carrying product code FCL. 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 |
|---|---|---|---|
| Bent | 77 | 19.3% | 10.2% |
| Breakthe device broke | 48 | 12% | 9% |
| Insufficient device problem information | 14 | 3.5% | 2.8% |
| Detachment of device component | 13 | 3.3% | 4% |
| Difficult to removethe device was hard to remove | 12 | 3% | 2.7% |
| Mechanical jam | 7 | 1.8% | 0.9% |
| Other (for use when an appropriate device code cannot be identified) | 7 | 1.8% | 6.3% |
| Material protrusion/extrusion | 6 | 1.5% | 1.1% |
| Close, difficult to | 5 | 1.3% | 2.3% |
| Normal | 4 | 1% | 1% |
| Entrapment of device | 3 | 0.8% | 0.4% |
| Fracturea broken bone | 3 | 0.8% | 1.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.5% | 15.8% |
| Difficult to open or close | 2 | 0.5% | 5.1% |
| Collapse | 1 | 0.3% | 0% |
| Component missing | 1 | 0.3% | 0.5% |
| Component(s), broken | 1 | 0.3% | 0.9% |
| Device contamination with chemical or other material | 1 | 0.3% | 2% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.3% | 0.8% |
| Device inoperablethe device could not be used | 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 |
|---|---|---|
| Blood loss | 18 | 4.5% |
| Hemorrhage/blood loss/bleeding | 13 | 3.3% |
| Bleeding | 8 | 2% |
| Bowel perforation | 8 | 2% |
| Tissue damage | 8 | 2% |
| Hematomaa collection of blood under the skin or in tissue | 7 | 1.8% |
| Painpain, site not specified | 5 | 1.3% |
| Deaththe patient died; cause not stated by this term | 4 | 1% |
| Perforation | 4 | 1% |
| Abdominal painstomach or belly pain | 3 | 0.8% |
| Hospitalization required | 3 | 0.8% |
| Chest painchest pain | 2 | 0.5% |
| Discomfortdiscomfort | 2 | 0.5% |
| No patient involvement | 2 | 0.5% |
| Therapy/non-surgical treatment, aborted/stopped | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Radial Jaw 4 Biopsy Forceps | Product code FCL | All MAUDE reports |
|---|---|---|---|
| Reports | 399 | 2,711 | 26,136,888 |
| Share of that pool | — | 14.7% | 0% |
| Classified as death, per 1,000 reports | 10 | 6 | 9 |
| Classified as injury | 27.8% | 26% | 36.2% |
| Classified as malfunction | 71.2% | 72.3% | 62.3% |
| Filed by the manufacturer | 100% | 93.1% | 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 FCL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Radial Jaw 4 | 403 | 22 | 0.5% |
| Radial Jaw 3 Biopsy Forceps | 302 | 0 | 0% |
| Captura Serrated Forceps With Spike | 223 | 0 | 0% |
| Disposable Biopsy Forceps | 201 | 8 | 0% |
| Karl Storz | 633 | 0 | 2.1% |
| Boston Scientific | 580 | 5 | 3.3% |
| Instinct Endoscopic Hemoclip | 784 | 0 | 0.1% |
| Superdimension | 227 | 5 | 7% |
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 Radial Jaw 4 Biopsy Forceps reports
How many FDA reports name Radial Jaw 4 Biopsy Forceps?
399 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 (71.2%), injury (27.8%) and death (1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
bent (19.3%), break (12%), insufficient device problem information (3.5%), detachment of device component (3.3%) and difficult to remove (3%). 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 Radial Jaw 4 Biopsy Forceps 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.