Reported Reactions

Devices › Table, operating-room, electrical

Device brand name · Table operating-room electrical

Spider 2 Tenet 7615: medical device reports filed with FDA

417 reports name it, 2015–2026. Manufacturer given most often on reports: Smith & Nephew. Product code GDC.

417
device reports naming the brand
0% of all MAUDE reports · about 37 a year
5
reports, 12 months to August 2026
8 in the 12 months before
95.9%
classified as malfunction
84.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

417 medical device reports received by FDA name the brand "Spider 2 Tenet 7615" (table operating-room electrical); the manufacturer given most often on reports is Smith & Nephew; received from March 2015 to February 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

5 reports arrived in the 12 months to August 2026, down 37% from 8 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 (95.9%) and injury (4.1%); across all table, operating-room, electrical reports (product code GDC) death is recorded in 0.1% and malfunction in 84.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are unstable (15.8%), physical resistance/sticking (9.8%) and positioning failure (8.9%). 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

023Sep 2021: 0Oct 2021: 0Nov 2021: 1Dec 2021: 12022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 1Jul 2022: 1Aug 2022: 0Sep 2022: 2Oct 2022: 1Nov 2022: 1Dec 2022: 02023Jan 2023: 1Feb 2023: 2Mar 2023: 1Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 1Aug 2023: 2Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 3Feb 2024: 0Mar 2024: 2Apr 2024: 1May 2024: 2Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 1Apr 2025: 0May 2025: 0Jun 2025: 3Jul 2025: 2Aug 2025: 2Sep 2025: 1Oct 2025: 0Nov 2025: 0Dec 2025: 12026Jan 2026: 1Feb 2026: 2Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

0761512015: 320152016: 102017: 3120172018: 242019: 2820192020: 1512021: 13620212022: 62023: 720232024: 82025: 1020252026: 3

Event type and report source

Event type, as classified on the report

Death0%0
Injury4.1%17
Malfunction95.9%400
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%417
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 1,615 reports carrying product code GDC. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Unstable6615.8%7.9%
Physical resistance/sticking419.8%4.9%
Positioning failure378.9%3.3%
Leak/splashthe device leaked266.2%2.6%
Positioning problem266.2%3.7%
Unintended movement174.1%25%
Mechanical jam163.8%1.5%
Failure to power up153.6%1.3%
Fluid/blood leak153.6%1.5%
Material too rigid or stiff143.4%1.4%
Noise, audible143.4%1.7%
Mechanical problema mechanical problem112.6%3.2%
Device operates differently than expectedthe device behaved unexpectedly102.4%4.1%
Decrease in pressure81.9%0.8%
Breakthe device broke71.7%2.2%
Loose or intermittent connection71.7%0.8%
Battery problema problem with the battery61.4%1.9%
Component falling51.2%1.2%
Material deformation41%0.3%
Overheating of device41%2.1%

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 involvement7918.9%

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

In context

MeasureSpider 2 Tenet 7615Product code GDCAll MAUDE reports
Reports4171,61526,136,888
Share of that pool—25.8%0%
Classified as death, per 1,000 reports019
Classified as injury4.1%6.7%36.2%
Classified as malfunction95.9%84.6%62.3%
Filed by the manufacturer100%87.5%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 GDC

BrandReportsLatest 12 monthsClassified as death
Svce Repl Spider 2 Tenet 761517300%
Skytron21710.9%
4085 Surgical Table24770%

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 Spider 2 Tenet 7615 reports

How many FDA reports name Spider 2 Tenet 7615?

417 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.

What kinds of events are reported?

malfunction (95.9%) and injury (4.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

unstable (15.8%), physical resistance/sticking (9.8%), positioning failure (8.9%), leak/splash (6.2%) and positioning problem (6.2%). 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 Spider 2 Tenet 7615 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.