COVIDIEN SURGICAL

FDA MAUDE device safety record · 2010–2026

What the Data Shows About COVIDIEN SURGICAL

COVIDIEN SURGICAL is associated with 4,272 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2010 through 2026. Of the total, 16 are coded as death reports and 362 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 15 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for COVIDIEN SURGICAL should be reviewed at the device-family level rather than company-wide. Across those devices, 3 distinct event types appear in the record, led by Malfunction at 3,894 reports (91.2% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 10 years of MAUDE data, with the peak single-year volume reaching 3,188 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

4,272
Total Reports
16
Death Reports
362
Injury Reports
15
Device Types

Event Types

Malfunction 3,894 (91.2%)
Injury 362 (8.5%)
Death 16 (0.4%)

Patient Outcomes

3,828 (88.2%)
Required Intervention 284 (6.5%)
Other 53 (1.2%)
R 49 (1.1%)
Hospitalization 44 (1.0%)
H 34 (0.8%)
O 12 (0.3%)
Death 12 (0.3%)
S 8 (0.2%)
Life Threatening 6 (0.1%)
Disability 4 (0.1%)
D 3 (0.1%)
L 3 (0.1%)

Yearly Trend

10
2010: 1
11
2011: 1
12
2012: 1
13
2013: 2
19
2019: 2
20
2020: 2
23
2023: 3
24
2024: 22
25
2025: 3,188
26
2026: 1,050

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 manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.