Device brand name · Esteem ii product code oaf

Esteem: medical device reports filed with FDA

236 reports name it, 2013–2026. Manufacturer given most often on reports: Envoy Medical.

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.

236
device reports naming the brand: 0% of all MAUDE reports · about 17 a year; 12
reports, 12 months to August 2026: 11 in the 12 months before; 27.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0 reports · not verified by FDA

236 medical device reports received by FDA name the brand "Esteem" (esteem ii product code oaf); the manufacturer given most often on reports is Envoy Medical; received from January 2013 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

12 reports arrived in the 12 months to August 2026, close to the 11 of 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 (49.6%), malfunction (27.5%) and other (22.9%). Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are insufficient device problem information (11.9%), device operates differently than expected (10.6%) and complete blockage (6.4%). The patient problems coded most often are wound dehiscence, hearing impairment and neurological deficit/dysfunction. 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

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

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury49.6%117

Malfunction27.5%65

Other22.9%54

Not given0%0

Who filed the report

Manufacturer report98.7%233

Voluntary report0.8%2

User facility report0%0

Distributor report0%0

Not given0.4%1

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	28	11.9%
Device operates differently than expectedthe device behaved unexpectedly	25	10.6%
Complete blockage	15	6.4%
Melted	15	6.4%
Premature discharge of battery	14	5.9%
Device inoperablethe device could not be used	11	4.7%
Electrical /electronic property probleman electrical or electronic problem	7	3%
Incomplete or inadequate connection	6	2.5%
Low impedance	6	2.5%
Impedance problem	5	2.1%
Patient device interaction problem	5	2.1%
Improper or incorrect procedure or method	4	1.7%
Patient-device incompatibilitythe device did not suit the patient	4	1.7%
Battery problema problem with the battery	2	0.8%
Device damaged by another device	2	0.8%
Fluid/blood leak	2	0.8%
Improper device output	2	0.8%
Intermittent continuity	2	0.8%
Material split, cut or torn	2	0.8%
Physical property issue	2	0.8%

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
Wound dehiscencea wound reopened	39	16.5%
Hearing impairment	31	13.1%
Neurological deficit/dysfunction	17	7.2%
Post operative wound infection	11	4.7%
Deafnesshearing loss	9	3.8%
Discomfortdiscomfort	8	3.4%
Partial hearing loss	6	2.5%
Painpain, site not specified	3	1.3%
Wound infectionan infected wound	3	1.3%
Complaint, ill-defined	2	0.8%
Feeding problem	2	0.8%
Hemorrhage/blood loss/bleeding	2	0.8%
Cellulitisa skin infection	1	0.4%
Chillschills or shivering	1	0.4%
Disability	1	0.4%

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

In context

Measure	Esteem	All MAUDE reports
Reports	236	26,136,888
Share of that pool	—	0%
Classified as death, per 1,000 reports	0	9
Classified as injury	49.6%	36.2%
Classified as malfunction	27.5%	62.3%
Filed by the manufacturer	98.7%	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."

Questions about Esteem reports

How many FDA reports name Esteem?

236 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.

What kinds of events are reported?

injury (49.6%), malfunction (27.5%) and other (22.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (11.9%), device operates differently than expected (10.6%), complete blockage (6.4%), melted (6.4%) and premature discharge of battery (5.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (98.7%) and voluntary reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Esteem 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.