Reported Reactions

Devices › Stretcher, wheeled

Device brand name · Hospital wheeled stretcher

Eye Surgery Stretcher: medical device reports filed with FDA

590 reports name it, 2007–2026. Manufacturer given most often on reports: Stryker Medical. Product code FPO.

590
device reports naming the brand
0% of all MAUDE reports · about 31 a year
15
reports, 12 months to August 2026
22 in the 12 months before
93.6%
classified as malfunction
93.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 590 reports that name the brand "Eye Surgery Stretcher" (hospital wheeled stretcher), received between May 2007 and July 2026; the manufacturer given most often on reports is Stryker Medical. Spellings of one product vary from report to report.

15 reports arrived in the 12 months to August 2026, down 32% from 22 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 (93.6%), injury (3.6%) and other (1.4%); across all stretcher, wheeled reports (product code FPO) death is recorded in 0.3% and malfunction in 93.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are device slipped (23.4%), unintended system motion (13.2%) and sticking (8.1%). The patient problems coded most often are no patient involvement, eye injury and inflammation. 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

047Sep 2021: 0Oct 2021: 5Nov 2021: 1Dec 2021: 02022Jan 2022: 4Feb 2022: 0Mar 2022: 0Apr 2022: 6May 2022: 0Jun 2022: 1Jul 2022: 4Aug 2022: 0Sep 2022: 0Oct 2022: 5Nov 2022: 0Dec 2022: 02023Jan 2023: 6Feb 2023: 0Mar 2023: 2Apr 2023: 6May 2023: 0Jun 2023: 0Jul 2023: 7Aug 2023: 0Sep 2023: 0Oct 2023: 6Nov 2023: 0Dec 2023: 02024Jan 2024: 6Feb 2024: 0Mar 2024: 0Apr 2024: 6May 2024: 1Jun 2024: 0Jul 2024: 5Aug 2024: 0Sep 2024: 0Oct 2024: 6Nov 2024: 0Dec 2024: 02025Jan 2025: 7Feb 2025: 0Mar 2025: 0Apr 2025: 5May 2025: 0Jun 2025: 0Jul 2025: 4Aug 2025: 0Sep 2025: 0Oct 2025: 3Nov 2025: 0Dec 2025: 02026Jan 2026: 3Feb 2026: 0Mar 2026: 0Apr 2026: 3May 2026: 0Jun 2026: 0Jul 2026: 6Aug 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

0631262007: 320072008: 42009: 2320092010: 802011: 11420112012: 1262013: 5020132014: 62018: 1720182019: 162020: 2020202021: 292022: 2020222023: 272024: 2420242025: 192026: 122026

Event type and report source

Event type, as classified on the report

Death0%0
Injury3.6%21
Malfunction93.6%552
Other1.4%8
Not given1.5%9

Who filed the report

Manufacturer report100%590
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 35,248 reports carrying product code FPO. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Device slipped13823.4%33.9%
Unintended system motionthe device moved when it should not have7813.2%3.5%
Sticking488.1%8.9%
Unintended head motion355.9%1.8%
Device fell345.8%1.7%
Breakthe device broke315.3%11.8%
Mechanical jam294.9%3.7%
Device operates differently than expectedthe device behaved unexpectedly274.6%5.2%
Fluid/blood leak274.6%2.3%
Unstable254.2%0.4%
Device inoperablethe device could not be used162.7%1.9%
Unintended movement162.7%3.3%
Mechanical problema mechanical problem142.4%5.5%
Positioning failure132.2%1.3%
Bent111.9%1.6%
Failure to pump91.5%0.8%
Device tipped over81.4%1.3%
Sharp edges71.2%1.1%
Leak/splashthe device leaked61%1.1%
Component falling50.8%1.1%

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 involvement7612.9%
Eye injury50.8%
Inflammationinflammation40.7%
Injurya physical injury40.7%
Painpain, site not specified30.5%
Bruise/contusion20.3%
Hemorrhage/blood loss/bleeding20.3%
Laceration(s)20.3%
Abrasion10.2%
Falla fall10.2%
Respiratory arrestbreathing stopped10.2%
Retinal injury10.2%
Retinal tear10.2%
Swelling/ edema10.2%
Visual impairmentreduced vision10.2%

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

In context

MeasureEye Surgery StretcherProduct code FPOAll MAUDE reports
Reports59035,24826,136,888
Share of that pool—1.7%0%
Classified as death, per 1,000 reports039
Classified as injury3.6%3.4%36.2%
Classified as malfunction93.6%93.7%62.3%
Filed by the manufacturer100%98.1%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 FPO

BrandReportsLatest 12 monthsClassified as death
Transtar Stretcher5,75150%
Sm204 M-Series W/Big Wheel2,79670%
Power Pro Ambulance Cot3,61500.4%
Sm104 M-Series W/5th Wheel98500%
Procedural stretcher9282110%
Mx-Pro R-3 Ambulance Cot99441.5%
Sm104 Mseries W5th Whl87400%
Power Pro Ambulance Cot - Obs657111.4%
Advantage Series 2664000%
Sm104 Mseries W5th Whlobs3/0751950.4%
Gynnie Ob-Gyn Stretcher563110%
Power Load46381.5%
Prime Big Wheel Stretcher 30444210%
Advantage Series 2944600%
St104 Transport43440%

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 Eye Surgery Stretcher reports

How many FDA reports name Eye Surgery Stretcher?

590 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.

What kinds of events are reported?

malfunction (93.6%), injury (3.6%) and other (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device slipped (23.4%), unintended system motion (13.2%), sticking (8.1%), unintended head motion (5.9%) and device fell (5.8%). 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 Eye Surgery Stretcher 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.