Lavage, jet: medical device reports filed with FDA

4,932 reports carry this product code, 1993–2026; 9 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

4,932
reports with this product code: 0% of all MAUDE reports; 685
reports, 12 months to August 2026: 688 in the 12 months before; 92.6%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code FQH is FDA's classification for "Lavage, jet" (general Hospital panel), a class 2 device. 4,932 medical device reports carry this product code, 0% of the MAUDE database, from July 1993 to August 2026.

685 reports arrived in the 12 months to August 2026, close to the 688 of 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 (92.6%), injury (6.7%) and other (0.3%). 9 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Fan Spray Kit	843	173	0%	98.2%
Hip Kit	651	135	0%	96.8%
Elefant suction-irrigation device	290	182	0%	100%
BD Surgiphor Sterile Wound Irrigation System	268	101	0%	75%
Versajet Exact Assy 45 Degree X 14mm	150	4	0%	92%
Zimmer Skin Graft Mesher	2	285	0%	96%
Renasys Touch Device & Power Sup	1	0	0%	93.7%
Stryker	1	5	1.3%	46.3%
Zimmer Air Dermatome	1	372	0%	79.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Zimmer Surgical	1,932	39.2%
Smith & Nephew Medical	769	15.6%
Coloplast A/S	286	5.8%
Carefusion	271	5.5%
Maquet Cv	123	2.5%
Davol Sub C R Bard	89	1.8%
Stryker Instruments-Kalamazoo	60	1.2%
Maquet Cardiovascular	54	1.1%
Stryker Instruments	42	0.9%
Stryker Instruments-A Division Of Stryker	35	0.7%
Davol	31	0.6%
Davol Sub C R Bard -1213643	22	0.4%
Smith & Nephew	9	0.2%
Medtronic Xomed	7	0.1%
Stryker Endoscopy Puerto Rico	5	0.1%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.1%5

Injury6.7%330

Malfunction92.6%4,567

Other0.3%16

Not given0.3%14

Who filed

Manufacturer report95.2%4,695

Voluntary report2%101

User facility report0%0

Distributor report0%1

Not given2.7%135

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Inability to irrigate	464	9.4%
Delivered as unsterile product	443	9%
Suction failure	278	5.6%
Battery problema problem with the battery	272	5.5%
Overheating of device	270	5.5%
Detachment of device or device componentpart of the device came off	240	4.9%
Breakthe device broke	225	4.6%
Crackthe device cracked	224	4.5%
Leak/splashthe device leaked	188	3.8%
Fluid/blood leak	182	3.7%
Detachment of device component	169	3.4%
Disassembly	138	2.8%
Mechanical problema mechanical problem	129	2.6%
Failure to power up	127	2.6%
Device contaminated during manufacture or shipping	123	2.5%
No flow	116	2.4%
Expulsion	111	2.3%
Smoking	83	1.7%
Difficult to insertthe device was hard to insert	79	1.6%
Component falling	75	1.5%

Questions about lavage, jet reports

What is product code FQH?

FDA's classification code for "Lavage, jet", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

4,932 reports through August 2026, 685 of them in the latest 12 months.

Which brands appear most often?

Fan Spray Kit (843), Hip Kit (651), Elefant suction-irrigation device (290), BD Surgiphor Sterile Wound Irrigation System (268) and Versajet Exact Assy 45 Degree X 14mm (150). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.