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Lavage, Jet

Open-data reference.

FDA MAUDE adverse event data · 1993–2026

What the Data Shows About Lavage, Jet

The FDA MAUDE database aggregates 4,670 adverse-event reports for Lavage, Jet spanning the period from 1993 through 2026. Of these, 5 are classified as death reports, 324 as injury reports, and 4,316 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 6 distinct event types and 11 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Inability to Irrigate topping the list at 442 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 34 years of MAUDE data, with the peak single-year volume reaching 845 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 11 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

4,670
Total Reports
5
Death Reports
324
Injury Reports
4,316
Malfunctions

Event Types

Malfunction 4,316 (92.4%)
Injury 324 (6.9%)
13 (0.3%)
Other 11 (0.2%)
Death 5 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

4,297 (91.5%)
Required Intervention 187 (4.0%)
Other 144 (3.1%)
Hospitalization 26 (0.6%)
R 25 (0.5%)
Death 6 (0.1%)
O 5 (0.1%)
H 2 (0.0%)
Invalid Data 2 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Inability to Irrigate 442
Delivered as Unsterile Product 407
Suction Failure 272
Battery Problem 241
Detachment of Device or Device Component 223
Crack 177
Overheating of Device 171
Fluid/Blood Leak 131
Device Contaminated During Manufacture or Shipping 116
Failure to Power Up 115
No Flow 115
Expulsion 112
Leak/Splash 104
Adverse Event Without Identified Device or Use Problem 90
Break 83
Mechanical Problem 80
Difficult to Insert 79
Explosion 70
Biocompatibility 67
Failure to Prime 65

Yearly Trend

93
1993: 1
94
1994: 2
95
1995: 1
96
1996: 5
97
1997: 12
98
1998: 9
99
1999: 6
00
2000: 7
01
2001: 5
02
2002: 5
03
2003: 4
04
2004: 8
05
2005: 7
06
2006: 11
07
2007: 10
08
2008: 27
09
2009: 70
10
2010: 135
11
2011: 83
12
2012: 133
13
2013: 134
14
2014: 194
15
2015: 116
16
2016: 150
17
2017: 243
18
2018: 317
19
2019: 328
20
2020: 393
21
2021: 398
22
2022: 171
23
2023: 333
24
2024: 425
25
2025: 845
26
2026: 82

Related Entities for Lavage, Jet

Event Locations

2,643 (56.6%)
I 1,775 (38.0%)
HOSPITAL 199 (4.3%)
NO INFORMATION 30 (0.6%)
INVALID DATA 8 (0.2%)
OTHER 6 (0.1%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
LABORATORY 2 (0.0%)
UNKNOWN 2 (0.0%)
NURSING HOME 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare ZIMMER SURGICAL, INC. vs SMITH & NEPHEW MEDICAL LTD. →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.