Reported Reactions

Devices › Arthroscope

Device brand name · Arthroscope and accessories

Main Pump Tubing: medical device reports filed with FDA

156 reports name it, 2007–2026. Manufacturer given most often on reports: Arthrex. Product code HRX.

156
device reports naming the brand
0% of all MAUDE reports · about 8 a year
24
reports, 12 months to August 2026
20 in the 12 months before
71.2%
classified as malfunction
87% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 156 reports that name the brand "Main Pump Tubing" (arthroscope and accessories), received between January 2007 and August 2026; the manufacturer given most often on reports is Arthrex. Spellings of one product vary from report to report.

24 reports arrived in the 12 months to August 2026, up 20% from 20 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 (71.2%), injury (26.9%) and other (1.9%); 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 increase in pressure (16.7%), pressure problem (12.2%) and defective device (9%). The patient problems coded most often are swelling/ edema and extravasation. 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

01325Sep 2021: 0Oct 2021: 1Nov 2021: 1Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 1Apr 2022: 0May 2022: 1Jun 2022: 0Jul 2022: 1Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 1Feb 2023: 2Mar 2023: 1Apr 2023: 1May 2023: 1Jun 2023: 1Jul 2023: 4Aug 2023: 6Sep 2023: 3Oct 2023: 3Nov 2023: 2Dec 2023: 22024Jan 2024: 3Feb 2024: 4Mar 2024: 1Apr 2024: 5May 2024: 25Jun 2024: 10Jul 2024: 3Aug 2024: 2Sep 2024: 3Oct 2024: 3Nov 2024: 1Dec 2024: 32025Jan 2025: 0Feb 2025: 2Mar 2025: 5Apr 2025: 0May 2025: 1Jun 2025: 0Jul 2025: 1Aug 2025: 1Sep 2025: 0Oct 2025: 1Nov 2025: 2Dec 2025: 32026Jan 2026: 1Feb 2026: 2Mar 2026: 2Apr 2026: 4May 2026: 3Jun 2026: 1Jul 2026: 2Aug 2026: 3

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

032632007: 320072008: 42010: 320102012: 42019: 520192020: 52021: 520212022: 32023: 2720232024: 632025: 1620252026: 18

Event type and report source

Event type, as classified on the report

Death0%0
Injury26.9%42
Malfunction71.2%111
Other1.9%3
Not given0%0

Who filed the report

Manufacturer report99.4%155
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.6%1

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
Increase in pressure2616.7%4.5%
Pressure problem1912.2%2.3%
Defective devicethe device was defective149%0.8%
Excess flow or over-infusion95.8%1.4%
Material deformation95.8%0.7%
No flow53.2%0.3%
Infusion or flow problema problem with flow or infusion42.6%1.8%
Breakthe device broke31.9%12.5%
Leak/splashthe device leaked31.9%2.2%
Material twisted/bent31.9%0.2%
Patient device interaction problem31.9%0.1%
Connection problema connection problem21.3%0.2%
Defective component21.3%0.2%
Device damaged prior to usethe device was damaged before use21.3%0.1%
Blocked connection10.6%0.2%
Collapse10.6%0.1%
Complete blockage10.6%0%
Component missing10.6%0.7%
Device dislodged or dislocated10.6%0%
Failure to shut off10.6%0.2%

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
Swelling/ edema1610.3%
Extravasation149%

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

In context

MeasureMain Pump TubingProduct code HRXAll MAUDE reports
Reports15625,68326,136,888
Share of that pool—0.6%0%
Classified as death, per 1,000 reports019
Classified as injury26.9%10.6%36.2%
Classified as malfunction71.2%87%62.3%
Filed by the manufacturer99.4%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 Main Pump Tubing reports

How many FDA reports name Main Pump Tubing?

156 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 24 in the latest 12 months.

What kinds of events are reported?

malfunction (71.2%), injury (26.9%) and other (1.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

increase in pressure (16.7%), pressure problem (12.2%), defective device (9%), excess flow or over-infusion (5.8%) and material deformation (5.8%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Main Pump Tubing 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.