STRYKER ENDOSCOPY-SAN JOSE

FDA MAUDE device safety record · 2013–2026

What the Data Shows About STRYKER ENDOSCOPY-SAN JOSE

STRYKER ENDOSCOPY-SAN JOSE is associated with 12,356 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2013 through 2026. Of the total, 8 are coded as death reports and 1,259 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 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for STRYKER ENDOSCOPY-SAN JOSE 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 11,089 reports (89.7% of total). Patient-outcome categorizations are reported across 7 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 14 years of MAUDE data, with the peak single-year volume reaching 1,340 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.

12,356
Total Reports
8
Death Reports
1,259
Injury Reports
20
Device Types

Event Types

Malfunction 11,089 (89.7%)
Injury 1,259 (10.2%)
Death 8 (0.1%)

Patient Outcomes

11,132 (90.1%)
Other 1,197 (9.7%)
Death 11 (0.1%)
O 3 (0.0%)
Hospitalization 3 (0.0%)
Required Intervention 2 (0.0%)
Disability 1 (0.0%)

Yearly Trend

13
2013: 619
14
2014: 1,067
15
2015: 1,155
16
2016: 1,253
17
2017: 1,260
18
2018: 750
19
2019: 591
20
2020: 562
21
2021: 747
22
2022: 823
23
2023: 1,340
24
2024: 1,011
25
2025: 1,045
26
2026: 133

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.