Reported Reactions

Devices › Arthroscope

Device brand name · Arthroscope

Videoarthroscope Hd 4mm X 30 Deg: medical device reports filed with FDA

179 reports name it, 2015–2021. Manufacturer given most often on reports: Smith & Nephew. Product code HRX.

179
device reports naming the brand
0% of all MAUDE reports · about 16 a year
0
reports, 12 months to August 2026
0 in the 12 months before
97.2%
classified as malfunction
87% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

179 medical device reports received by FDA name the brand "Videoarthroscope Hd 4mm X 30 Deg" (arthroscope); the manufacturer given most often on reports is Smith & Nephew; received from July 2015 to June 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (97.2%) and injury (2.8%); across all arthroscope reports (product code HRX) death is recorded in 0.1% and malfunction in 87%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are no display/image (22.9%), poor quality image (19%) and device operates differently than expected (14%). The patient problems coded most often are no patient involvement. 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

No report naming Videoarthroscope Hd 4mm X 30 Deg was received in the five years to August 2026; the latest was received in June 2021.

By year received

0501002015: 320152016: 420162017: 10020172018: 2520182019: 2120192020: 620202021: 202021

Event type and report source

Event type, as classified on the report

Death0%0
Injury2.8%5
Malfunction97.2%174
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%179
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 25,683 reports carrying product code HRX. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
No display/image4122.9%1%
Poor quality image3419%2.4%
Device operates differently than expectedthe device behaved unexpectedly2514%1.7%
Crackthe device cracked168.9%2.1%
Scratched material137.3%1.5%
Breakthe device broke63.4%12.5%
Optical obstruction63.4%0.2%
Material opacification52.8%0.1%
Insufficient device problem information42.2%0.9%
Image display error/artifact31.7%0.1%
Device contamination with chemical or other material21.1%0.3%
Device inoperablethe device could not be used21.1%0.3%
Loose or intermittent connection21.1%0.1%
No device output21.1%0%
Overheating of device21.1%4.1%
Connection problema connection problem10.6%0.2%
Electrical shorting10.6%2.6%
Fogging10.6%0.6%
Material deformation10.6%0.7%
Material discolored10.6%0%

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)ReportsShare
No patient involvement10.6%

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

In context

MeasureVideoarthroscope Hd 4mm X 30 DegProduct code HRXAll MAUDE reports
Reports17925,68326,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports019
Classified as injury2.8%10.6%36.2%
Classified as malfunction97.2%87%62.3%
Filed by the manufacturer100%94.9%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."

Other brands with product code HRX

BrandReportsLatest 12 monthsClassified as death
Micro Tornado Hp W Handcontrol1,501460%
Dw Arthroscopy Fluid Management Dev1,0531580%
METRx System1,6792670.1%
Fms Vue Pump706370%
Hd Epscp 4 0 30 167 Mitek575270%
4k C-Mnt Scp 4 0 30 167 Mitek5412050%
Cordless Driver 347600%
Dii Controller35460%
Shaver Handpiece 2 0 With Buttons329870%
4580 Fms Duo+ Pump/Shaver Combo -Ns31620%
Kyphon Xpander Inflatable Bone Tamp315220%
Sagittal Saw Attachment1,505640%
Control Unit Dyonics 25287410%
Fms Tornado Micro Handpiece With Buttons28500%
Vapr3 Footswitch Ea24320%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Videoarthroscope Hd 4mm X 30 Deg reports

How many FDA reports name Videoarthroscope Hd 4mm X 30 Deg?

179 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (97.2%) and injury (2.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

no display/image (22.9%), poor quality image (19%), device operates differently than expected (14%), crack (8.9%) and scratched material (7.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Videoarthroscope Hd 4mm X 30 Deg 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.