Confocal optical imaging: medical device reports filed with FDA

1,559 reports carry this product code, 2015–2026; 7 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.

1,559
reports with this product code: 0% of all MAUDE reports; 258
reports, 12 months to August 2026: 172 in the 12 months before; 94.6%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code OWN is FDA's classification for "Confocal optical imaging" (gastroenterology, Urology panel), a class 2 device. 1,559 medical device reports carry this product code, 0% of the MAUDE database, from October 2015 to August 2026.

258 reports arrived in the 12 months to August 2026, up 50% from 172 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 (94.6%), injury (5.3%) and death (0.1%). 7 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
PKG L11 LED Light Source with AIM	246	31	0%	96.7%
Hd 3cmos Autoclavable Camera Head	217	727	0%	99.7%
Hd 3cmos Camera Head	92	572	0%	100%
Unknown_Endoscopy_Product	14	22	0.4%	69.7%
Allura Xper FD	2	5,580	0.1%	99.6%
4k Autoclavable Camera Head	1	723	0%	99.7%
C-MAC Video Laryngoscope MAC #4	1	150	0%	96.9%

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
Stryker Endoscopy-San Jose	659	42.3%
Karl Storz Se & Kg	110	7.1%
Stryker Endoscopy	5	0.3%
Olympus Medical System	1	0.1%
Philips Medical Systems Nederland	1	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

Death0.1%1

Injury5.3%82

Malfunction94.6%1,475

Other0.1%1

Not given0%0

Who filed

Manufacturer report97.6%1,522

Voluntary report0.5%8

User facility report0%0

Distributor report1.2%19

Not given0.6%10

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

Device problems coded

Device problem (FDA code)	Reports	Share
No display/image	398	25.5%
Output problem	300	19.2%
Poor quality image	135	8.7%
Optical problem	133	8.5%
Temperature problem	123	7.9%
Communication or transmission problemthe device could not communicate or transmit	118	7.6%
Electrical /electronic property probleman electrical or electronic problem	81	5.2%
Overheating of device	64	4.1%
Failure to power up	48	3.1%
Display or visual feedback problem	46	3%
Erratic or intermittent display	35	2.2%
Energy output problem	30	1.9%
Thermal decomposition of device	28	1.8%
Insufficient device problem information	24	1.5%
Fogging	22	1.4%
Optical distortion	22	1.4%
Breakthe device broke	21	1.3%
No device output	18	1.2%
Activation failure	17	1.1%
Connection problema connection problem	17	1.1%

Questions about confocal optical imaging reports

What is product code OWN?

FDA's classification code for "Confocal optical imaging", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,559 reports through August 2026, 258 of them in the latest 12 months.

Which brands appear most often?

PKG L11 LED Light Source with AIM (246), Hd 3cmos Autoclavable Camera Head (217), Hd 3cmos Camera Head (92), Unknown_Endoscopy_Product (14) and Allura Xper FD (2). 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.