ETHICON ENDO-SURGERY, LLC.

Manufacturer adverse-event records for ETHICON ENDO-SURGERY, LLC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2007–2026 · heavy-book · typical Death-code · balanced

Volume signature

ETHICON ENDO-SURGERY, LLC. sits in the heavy MAUDE book

ETHICON ENDO-SURGERY, LLC. accounts for 129,505 FDA MAUDE reports (#23 of 443, heavy-book tercile). Death-coded event_type share is 0.42% (typical); Injury share 9.6% (balanced).

What the volume reading shows for ETHICON ENDO-SURGERY, LLC.

The standout signal for ETHICON ENDO-SURGERY, LLC. is filing volume: 129,505 adverse-event reports in FDA MAUDE (#23 of 443, heavy-book). Death-coded event_type share sits at 0.42% (typical).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ETHICON ENDO-SURGERY, LLC. with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Malfunction at 116,246 (89.8% of event_type total). Peak single-year volume reaches 9,674 reports across 20 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

129,505
Total Reports
541
Event-type Death
12,470
Injury Reports
20
Device Types

Event Types

Malfunction 116,246 (89.8%)
Injury 12,470 (9.6%)
Death 541 (0.4%)
247 (0.2%)
Other 1 (0.0%)

Patient Outcomes

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

117,569 (89.9%)
Required Intervention 9,407 (7.2%)
Other 1,106 (0.8%)
R 989 (0.8%)
Hospitalization 735 (0.6%)
Death 470 (0.4%)
H 194 (0.1%)
O 96 (0.1%)
D 54 (0.0%)
Disability 51 (0.0%)
S 38 (0.0%)
Life Threatening 23 (0.0%)
L 7 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

07
2007: 2
08
2008: 751
09
2009: 2,814
10
2010: 6,668
11
2011: 5,764
12
2012: 5,860
13
2013: 7,252
14
2014: 8,932
15
2015: 8,325
16
2016: 7,184
17
2017: 6,596
18
2018: 7,642
19
2019: 8,023
20
2020: 6,830
21
2021: 7,924
22
2022: 8,624
23
2023: 9,674
24
2024: 9,561
25
2025: 9,499
26
2026: 1,580