COOK ENDOSCOPY

Manufacturer adverse-event records for COOK ENDOSCOPY 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 · 2005–2022 · thin-book · typical Death-code · balanced

Volume signature

COOK ENDOSCOPY is a thinner MAUDE footprint

COOK ENDOSCOPY accounts for 5,821 FDA MAUDE reports (#333 of 443, thin-book tercile). Death-coded event_type share is 0.34% (typical); Injury share 14.4% (balanced).

What the volume reading shows for COOK ENDOSCOPY

The standout signal for COOK ENDOSCOPY is filing volume: 5,821 adverse-event reports in FDA MAUDE (#333 of 443, thin-book). Death-coded event_type share sits at 0.34% (typical).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Malfunction at 4,952 (85.1% of event_type total). Peak single-year volume reaches 806 reports across 18 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,821
Total Reports
20
Event-type Death
841
Injury Reports
20
Device Types

Event Types

Malfunction 4,952 (85.1%)
Injury 841 (14.4%)
Death 20 (0.3%)
7 (0.1%)
Other 1 (0.0%)

Patient Outcomes

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

4,976 (84.0%)
Required Intervention 604 (10.2%)
Hospitalization 123 (2.1%)
R 94 (1.6%)
Other 80 (1.4%)
Death 19 (0.3%)
Life Threatening 13 (0.2%)
L 7 (0.1%)
O 3 (0.1%)
H 2 (0.0%)
S 2 (0.0%)
Disability 2 (0.0%)

Yearly Trend

05
2005: 20
06
2006: 131
07
2007: 168
08
2008: 179
09
2009: 229
10
2010: 685
11
2011: 18
12
2012: 2
13
2013: 10
14
2014: 16
15
2015: 242
16
2016: 506
17
2017: 787
18
2018: 594
19
2019: 806
20
2020: 575
21
2021: 722
22
2022: 131