Trocar: medical device reports filed with FDA

2,003 reports carry this product code, 1992–2026; 16 brands with a page.

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.

2,003
reports with this product code: 0% of all MAUDE reports; 95
reports, 12 months to August 2026: 65 in the 12 months before; 47.7%
classified as malfunction: 62.3% across all reports; 2.9%
classified as death, as reported: 0.9% across all reports

Product code DRC is FDA's classification for "Trocar" (cardiovascular panel), a class 2 device. 2,003 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

95 reports arrived in the 12 months to August 2026, up 46% from 65 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 (47.7%), injury (46.9%) and death (2.9%). 16 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Transseptal Needle, BRK Series	202	32	5.9%	2%
Spacemaker Blunt Tip Trocar 10mm	190	0	0%	95.1%
Spacemaker Blunt Tip Trocar 12mm	84	0	0%	94.1%
5 5mm Short Secondary Port	54	0	0%	92.1%
Spacemaker Structural Balloon Trocar	46	0	0%	95.6%
Heartlight	5	0	1%	6.8%
Autosuture	4	0	1.2%	63.1%
Endopath	4	74	1.4%	83.7%
Argyle	3	60	1%	82.4%
Auto Suture	3	234	0.1%	94.6%
Ethicon	3	164	2.3%	54.2%
Sm Plus Btt/Oval Balloon Dissector	2	0	0%	94.3%
Endopath Xcel	1	38	0.5%	95.2%
Kendall	1	23	2.3%	61.5%
NRG Transseptal Needle	1	24	4.2%	25.9%
Spacemaker Preperitoneal Dist Balloon	1	0	0%	95.8%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Ponce - Uss	339	16.9%
St Jude Medical	263	13.1%
St Jude Medical Costa Rica Ltda	140	7%
United States Surgical	82	4.1%
Medtronic Mexico	74	3.7%
Medtronic Mexico S De R L De Cv	21	1%
Ethicon	16	0.8%
Merit Medical Systems	16	0.8%
Applied Medical Resources	13	0.6%
Applied Medical	11	0.5%
Ethicon Endo-Surgery	7	0.3%
Cook	4	0.2%
Codman & Shurtleff	3	0.1%
Conmed	2	0.1%
Ethicon Endo Surgery	2	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death2.9%59

Injury46.9%940

Malfunction47.7%956

Other1.5%30

Not given0.9%18

Who filed

Manufacturer report89.2%1,786

Voluntary report5.3%107

User facility report0%0

Distributor report0.1%2

Not given5.4%108

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	214	10.7%
Detachment of device component	193	9.6%
Replace	185	9.2%
Balloon rupture	105	5.2%
Component(s), broken	96	4.8%
Balloon burst	94	4.7%
Device, removal of (non-implant)	88	4.4%
Component falling	86	4.3%
Disengaged	67	3.3%
Difficult to insertthe device was hard to insert	60	3%
Insufficient device problem information	58	2.9%
Material separation	50	2.5%
Activation, positioning or separation problem	32	1.6%
Fracturea broken bone	29	1.4%
Device, or device fragments remain in patient	28	1.4%
Air leak	26	1.3%
Trocar failure	25	1.2%
Inflation problem	23	1.1%
Difficult to removethe device was hard to remove	18	0.9%
Material fragmentation	18	0.9%

Questions about trocar reports

What is product code DRC?

FDA's classification code for "Trocar", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,003 reports through August 2026, 95 of them in the latest 12 months.

Which brands appear most often?

Transseptal Needle, BRK Series (202), Spacemaker Blunt Tip Trocar 10mm (190), Spacemaker Blunt Tip Trocar 12mm (84), 5 5mm Short Secondary Port (54) and Spacemaker Structural Balloon Trocar (46). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.