Arthroscope: medical device reports filed with FDA

25,683 reports carry this product code, 1992–2026; 30 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.

25,683
reports with this product code: 0.1% of all MAUDE reports; 2,026
reports, 12 months to August 2026: 2,228 in the 12 months before; 87%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code HRX is FDA's classification for "Arthroscope" (orthopedic panel), a class 2 device. 25,683 medical device reports carry this product code, 0.1% of the MAUDE database, from February 1992 to August 2026.

2,026 reports arrived in the 12 months to August 2026, close to the 2,228 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 malfunction (87%), injury (10.6%) and other (1.7%). 30 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
Micro Tornado Hp W Handcontrol	1,500	46	0%	99.9%
Dw Arthroscopy Fluid Management Dev	1,051	158	0%	91.5%
METRx System	706	267	0.1%	99%
Fms Vue Pump	704	37	0%	97.9%
Hd Epscp 4 0 30 167 Mitek	572	27	0%	100%
4k C-Mnt Scp 4 0 30 167 Mitek	529	205	0%	100%
Cordless Driver 3	436	0	0%	99.8%
Dii Controller	339	6	0%	96.3%
Shaver Handpiece 2 0 With Buttons	329	87	0%	100%
4580 Fms Duo+ Pump/Shaver Combo -Ns	316	2	0%	96.5%
Kyphon Xpander Inflatable Bone Tamp	306	22	0%	96.5%
Sagittal Saw Attachment	295	64	0%	99.3%
Control Unit Dyonics 25	285	41	0%	87.8%
Fms Tornado Micro Handpiece With Buttons	284	0	0%	99.6%
Vapr3 Footswitch Ea	236	2	0%	98.8%
Inflow Tubing Fms Vue 24pk	226	22	0%	96.9%
METRx(TM) System	213	113	0%	98.9%
Lupine Drill Guide	205	0	0%	99.1%
Wire Collet	197	3	0%	98.2%
8022 Handpc Tornado Shaver	191	0	0%	100%
Main Pump Tubing	156	24	0%	71.2%
Videoarthroscope Hd 4mm X 30 Deg	156	0	0%	97.2%
Hd Arthroscope/Sinuscope 4 0mm X 30 Deg X 167mm Mitek Lock	155	0	0%	100%
Cordless Driver 2 Handpiece	141	0	0%	100%
Camera Head Lens Int Sys	99	0	0%	96.6%
Advantage Turbo Shaver 2 Button Basic	83	0	0%	99.6%
Pin Collet	78	0	0%	99.5%
4 0mm Aggressive Plus Cutter Formula 5bx	73	0	0%	94.7%
Tps Handpiece Cord	64	0	0%	99.5%
Arthrex	58	28	0%	75.9%

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
Depuy Mitek US	5,245	20.4%
Arthrex	2,284	8.9%
Medos International S Rl	1,718	6.7%
Stryker Instruments-Kalamazoo	1,588	6.2%
Medos International Sarl	1,412	5.5%
Depuy Mitek	1,320	5.1%
Medtronic Sofamor Danek USA	1,100	4.3%
Smith & Nephew	1,097	4.3%
Stryker Endoscopy-San Jose	876	3.4%
Stryker Endoscopy	678	2.6%
Stryker Instruments Kalamazoo	525	2%
Olympus Winter & Ibe	446	1.7%
Conmed Linvatec	373	1.5%
Medtronic Mexico	359	1.4%
Stryker Endoscopy San Jose	276	1.1%

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%36

Injury10.6%2,731

Malfunction87%22,347

Other1.7%442

Not given0.5%127

Who filed

Manufacturer report94.9%24,368

Voluntary report2.5%632

User facility report0%0

Distributor report0.1%19

Not given2.6%664

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	3,210	12.5%
Increase in pressure	1,146	4.5%
Display or visual feedback problem	1,096	4.3%
Optical problem	1,050	4.1%
Overheating of device	1,042	4.1%
Material rupture	909	3.5%
Metal shedding debris	777	3%
Tip breakage	704	2.7%
Detachment of device or device componentpart of the device came off	694	2.7%
Electrical shorting	666	2.6%
Poor quality image	626	2.4%
Pressure problem	592	2.3%
Leak/splashthe device leaked	553	2.2%
Crackthe device cracked	548	2.1%
Electrical /electronic property probleman electrical or electronic problem	548	2.1%
Detachment of device component	486	1.9%
Improper flow or infusion	472	1.8%
Infusion or flow problema problem with flow or infusion	463	1.8%
Device operates differently than expectedthe device behaved unexpectedly	427	1.7%
Overfill	413	1.6%

Questions about arthroscope reports

What is product code HRX?

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

How many reports carry this code?

25,683 reports through August 2026, 2,026 of them in the latest 12 months.

Which brands appear most often?

Micro Tornado Hp W Handcontrol (1,500), Dw Arthroscopy Fluid Management Dev (1,051), METRx System (706), Fms Vue Pump (704) and Hd Epscp 4 0 30 167 Mitek (572). 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.