2026 data FDA MAUDE openFDA FDA Class II

Lavage, Jet

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5475 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Lavage, Jet LIGHT-BOOK · MAUDE

#324 of 1000 · 4,888 reports · 1993–2026

  • BOOK 4,888 reports
  • RANK #324 of 1000
  • DEATH 5 death-typed
  • INJ 330 injury-typed
  • MALF 4,528 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 845
  • PHOTO Biopsy Needle

Nearest event-volume peer: Biopsy Needle (4 report gap)

Lavage, Jet sits #324 of 1000 among tracked device types with 4,888 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Lavage, Jet carries 92.6% MALFUNCTION-coded reports, 27.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 6.8% corpus 30.3% · below corpus mean (-23.5 pp)
  • MALF 92.6% corpus 64.8% · above corpus mean (+27.8 pp)

Lead product-problem code Inability to Irrigate is 12% of coded problems · Lead manufacturer ZIMMER SURGICAL, INC. accounts for 52% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Lavage, Jet in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Lavage, Jet carries 4,888 MAUDE reports, ranked #324 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 4,528 (92.6%)
Injury 330 (6.8%)
13 (0.3%)
Other 11 (0.2%)
Death 5 (0.1%)
No answer provided 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

4,510 (91.8%)
Required Intervention 188 (3.8%)
Other 146 (3.0%)
Hospitalization 26 (0.5%)
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 466
Delivered as Unsterile Product 444
Suction Failure 278
Battery Problem 273
Overheating of Device 268
Detachment of Device or Device Component 243
Break 223
Crack 215
Leak/Splash 188
Fluid/Blood Leak 183
Detachment Of Device Component 169
Disassembly 140
Device Contaminated During Manufacture or Shipping 126
Failure to Power Up 126
Mechanical Problem 124
No Flow 118
Expulsion 112
Adverse Event Without Identified Device or Use Problem 100
Smoking 84
Difficult to Insert 79

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: 300

Reports rose to 845 in 2025, up from an average of 379 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Lavage, Jet

Event Locations

2,859 (58.5%)
I 1,775 (36.3%)
HOSPITAL 201 (4.1%)
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. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Lavage, Jet: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (4,888 here).

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Disclaimer: MAUDE figures for Lavage, Jet are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Lavage, Jet; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.