Device brand name · Fcl forceps biopsy non-electric

Captura Serrated Forceps With Spike: medical device reports filed with FDA

223 reports name it, 2009–2017. Manufacturer given most often on reports: Cook Endoscopy. Product code FCL.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

223
device reports naming the brand: 0% of all MAUDE reports · about 13 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 87.4%
classified as malfunction: 72.3% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 223 reports that name the brand "Captura Serrated Forceps With Spike" (fcl forceps biopsy non-electric), received between August 2009 and December 2017; the manufacturer given most often on reports is Cook Endoscopy. 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 (87.4%) and injury (12.1%); 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 device operates differently than expected (68.2%), failure to cut (11.2%) and insufficient device problem information (5.4%). The patient problems coded most often are hemorrhage/blood loss/bleeding, laceration(s) 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 Captura Serrated Forceps With Spike was received in the five years to August 2026; the latest was received in December 2017.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury12.1%27

Malfunction87.4%195

Other0%0

Not given0.4%1

Who filed the report

Manufacturer report99.1%221

Voluntary report0.4%1

User facility report0%0

Distributor report0%0

Not given0.4%1

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
Device operates differently than expectedthe device behaved unexpectedly	152	68.2%	15.8%
Failure to cut	25	11.2%	2.9%
Insufficient device problem information	12	5.4%	2.8%
Dull, blunt	7	3.1%	2%
Solder joint fracture	4	1.8%	0.2%
Failure to align	2	0.9%	1.3%
Improper or incorrect procedure or method	2	0.9%	0.1%
Mechanics altered	2	0.9%	0.1%
Cut in material	1	0.4%	0%
Difficult to open or close	1	0.4%	5.1%
Physical resistance	1	0.4%	0.1%
Retraction problem	1	0.4%	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
Hemorrhage/blood loss/bleeding	69	30.9%
Laceration(s)	64	28.7%
Tissue damage	26	11.7%
Hemostasis	9	4%
Hematomaa collection of blood under the skin or in tissue	5	2.2%
No patient involvement	4	1.8%
Perforation	2	0.9%
Blood loss	1	0.4%
Bowel perforation	1	0.4%
Thrombus	1	0.4%
Vomitingbeing sick	1	0.4%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Captura Serrated Forceps With Spike	Product code FCL	All MAUDE reports
Reports	223	2,711	26,136,888
Share of that pool	—	8.2%	0%
Classified as death, per 1,000 reports	0	6	9
Classified as injury	12.1%	26%	36.2%
Classified as malfunction	87.4%	72.3%	62.3%
Filed by the manufacturer	99.1%	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 Biopsy Forceps	399	0	1%
Radial Jaw 4	403	22	0.5%
Radial Jaw 3 Biopsy Forceps	302	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 Captura Serrated Forceps With Spike reports

How many FDA reports name Captura Serrated Forceps With Spike?

223 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 (87.4%) and injury (12.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device operates differently than expected (68.2%), failure to cut (11.2%), insufficient device problem information (5.4%), dull, blunt (3.1%) and solder joint fracture (1.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.1%) and voluntary reports (0.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Captura Serrated Forceps With Spike 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.