Reported Reactions

Devices › Lavage, jet

Device brand name · Lavage jet

Fan Spray Kit: medical device reports filed with FDA

850 reports name it, 2010–2026. Manufacturer given most often on reports: Zimmer Surgical. Product code FQH.

850
device reports naming the brand
0% of all MAUDE reports · about 53 a year
173
reports, 12 months to August 2026
199 in the 12 months before
98.2%
classified as malfunction
92.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 850 reports that name the brand "Fan Spray Kit" (lavage jet), received between July 2010 and August 2026; the manufacturer given most often on reports is Zimmer Surgical. Spellings of one product vary from report to report.

173 reports arrived in the 12 months to August 2026, down 13% from 199 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 (98.2%), injury (1.5%) and other (0.2%); across all lavage, jet reports (product code FQH) death is recorded in 0.1% and malfunction in 92.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are delivered as unsterile product (20.7%), battery problem (14.7%) and inability to irrigate (10.9%). The patient problems coded most often are no patient involvement, foreign body in patient and burn(s). 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

01733Sep 2021: 5Oct 2021: 6Nov 2021: 3Dec 2021: 12022Jan 2022: 1Feb 2022: 5Mar 2022: 6Apr 2022: 4May 2022: 7Jun 2022: 5Jul 2022: 1Aug 2022: 6Sep 2022: 3Oct 2022: 1Nov 2022: 0Dec 2022: 62023Jan 2023: 2Feb 2023: 7Mar 2023: 4Apr 2023: 2May 2023: 1Jun 2023: 4Jul 2023: 4Aug 2023: 9Sep 2023: 7Oct 2023: 9Nov 2023: 7Dec 2023: 62024Jan 2024: 5Feb 2024: 6Mar 2024: 10Apr 2024: 13May 2024: 13Jun 2024: 12Jul 2024: 16Aug 2024: 15Sep 2024: 9Oct 2024: 14Nov 2024: 12Dec 2024: 172025Jan 2025: 12Feb 2025: 17Mar 2025: 28Apr 2025: 33May 2025: 16Jun 2025: 22Jul 2025: 9Aug 2025: 10Sep 2025: 12Oct 2025: 16Nov 2025: 14Dec 2025: 72026Jan 2026: 9Feb 2026: 16Mar 2026: 6Apr 2026: 24May 2026: 17Jun 2026: 19Jul 2026: 20Aug 2026: 13

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

0981962010: 320102015: 92016: 2220162017: 682018: 2420182019: 282020: 6320202021: 642022: 4520222023: 622024: 14220242025: 1962026: 1242026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.5%13
Malfunction98.2%835
Other0.2%2
Not given0%0

Who filed the report

Manufacturer report99.8%848
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0.2%2

Grey bar: all 4,932 reports carrying product code FQH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Delivered as unsterile product17620.7%9%
Battery problema problem with the battery12514.7%5.5%
Inability to irrigate9310.9%9.4%
Detachment of device or device componentpart of the device came off8510%4.9%
Overheating of device627.3%5.5%
Device contaminated during manufacture or shipping526.1%2.5%
Expulsion445.2%2.3%
Mechanical problema mechanical problem394.6%2.6%
Failure to power up364.2%2.6%
Explosion354.1%1.5%
Leak/splashthe device leaked252.9%3.8%
Noise, audible242.8%1.3%
Fluid/blood leak232.7%3.7%
Pressure problem212.5%1.1%
Smoking202.4%1.7%
Activation problem192.2%0.8%
Corrodedthe device corroded192.2%1.4%
Disconnection161.9%1.2%
Melted111.3%0.9%
Powder leak111.3%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 involvement364.2%
Foreign body in patientpart of a device left in the patient50.6%
Burn(s)a burn10.1%
Device embedded in tissue or plaque10.1%
Injurya physical injury10.1%

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

In context

MeasureFan Spray KitProduct code FQHAll MAUDE reports
Reports8504,93226,136,888
Share of that pool—17.2%0%
Classified as death, per 1,000 reports019
Classified as injury1.5%6.7%36.2%
Classified as malfunction98.2%92.6%62.3%
Filed by the manufacturer99.8%95.2%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 FQH

BrandReportsLatest 12 monthsClassified as death
Hip Kit6521350%
Elefant suction-irrigation device2901820%
BD Surgiphor Sterile Wound Irrigation System2681010%
Versajet Exact Assy 45 Degree X 14mm15040%
Zimmer Skin Graft Mesher3,4632850%
Renasys Touch Device & Power Sup44700%
Stryker55951.3%
Zimmer Air Dermatome2,6873720%

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 Fan Spray Kit reports

How many FDA reports name Fan Spray Kit?

850 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 173 in the latest 12 months.

What kinds of events are reported?

malfunction (98.2%), injury (1.5%) and other (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

delivered as unsterile product (20.7%), battery problem (14.7%), inability to irrigate (10.9%), detachment of device or device component (10%) and overheating of device (7.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Fan Spray Kit 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.