Transcervical contraceptive tubal occlusion device: medical device reports filed with FDA

74,519 reports carry this product code, 1994–2026; 3 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.

74,519
reports with this product code: 0.3% of all MAUDE reports; 474
reports, 12 months to August 2026: 854 in the 12 months before; 1.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code HHS is FDA's classification for "Transcervical contraceptive tubal occlusion device" (obstetrics/Gynecology panel), a class 3 device. 74,519 medical device reports carry this product code, 0.3% of the MAUDE database, from May 1994 to August 2026.

474 reports arrived in the 12 months to August 2026, down 44% from 854 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 injury (97.8%), malfunction (1.4%) and other (0.3%). 3 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
Essure	73,990	435	0.2%	1.4%
Colleague Volumetric Infusion Pump	4	0	0.1%	99.1%
Filshie Clips	4	6	0%	0.8%

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
Bayer Pharma	63,497	85.2%
Bayer	7,790	10.5%
Bayer Healthcare	1,413	1.9%
Conceptus	1,228	1.6%
Baxter Healthcare Pte	2	0%
Baxter Healthcare Sg	2	0%
Hologic	2	0%
Applied Medical Resources	1	0%

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

Death0.2%136

Injury97.8%72,872

Malfunction1.4%1,077

Other0.3%238

Not given0.3%196

Who filed

Manufacturer report85.9%63,986

Voluntary report13.9%10,377

User facility report0%0

Distributor report0%0

Not given0.2%156

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	17,068	22.9%
Patient-device incompatibilitythe device did not suit the patient	5,659	7.6%
Biocompatibility	5,472	7.3%
Device dislodged or dislocated	5,303	7.1%
Breakthe device broke	4,939	6.6%
Migrationthe device moved from where it was placed	4,816	6.5%
Migration or expulsion of device	3,401	4.6%
Expulsion	2,251	3%
Device operates differently than expectedthe device behaved unexpectedly	1,068	1.4%
Patient device interaction problem	513	0.7%
Malposition of device	428	0.6%
Difficult to removethe device was hard to remove	369	0.5%
Difficult to insertthe device was hard to insert	361	0.5%
Mechanical problema mechanical problem	277	0.4%
Positioning failure	203	0.3%
Material integrity problema problem with the device material	196	0.3%
Entrapment of device	189	0.3%
Material fragmentation	168	0.2%
Fracturea broken bone	161	0.2%
Extrusion	160	0.2%

Questions about transcervical contraceptive tubal occlusion device reports

What is product code HHS?

FDA's classification code for "Transcervical contraceptive tubal occlusion device", class 3, reviewed by the obstetrics/Gynecology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

74,519 reports through August 2026, 474 of them in the latest 12 months.

Which brands appear most often?

Essure (73,990), Colleague Volumetric Infusion Pump (4) and Filshie Clips (4). 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.