UNITED STATES SURGICAL CORPORATION

FDA MAUDE device safety record · 1992–2011

What the Data Shows About UNITED STATES SURGICAL CORPORATION

UNITED STATES SURGICAL CORPORATION is associated with 3,776 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2011. Of the total, 15 are coded as death reports and 381 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 UNITED STATES SURGICAL CORPORATION should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 3,330 reports (88.2% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 766 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.

3,776
Total Reports
15
Death Reports
381
Injury Reports
20
Device Types

Event Types

Malfunction 3,330 (88.2%)
Injury 381 (10.1%)
26 (0.7%)
Other 24 (0.6%)
Death 15 (0.4%)

Patient Outcomes

3,338 (87.5%)
Other 201 (5.3%)
Required Intervention 198 (5.2%)
R 33 (0.9%)
Hospitalization 20 (0.5%)
Death 12 (0.3%)
Life Threatening 5 (0.1%)
L 2 (0.1%)
O 2 (0.1%)
Invalid Data 2 (0.1%)
H 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

92
1992: 16
93
1993: 12
94
1994: 17
95
1995: 2
96
1996: 329
97
1997: 766
98
1998: 672
99
1999: 540
00
2000: 751
01
2001: 429
02
2002: 1
03
2003: 9
04
2004: 14
05
2005: 58
06
2006: 78
07
2007: 81
11
2011: 1

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.