UNITED STATES SURGICAL CORP.

FDA MAUDE device safety record · 1992–2005

What the Data Shows About UNITED STATES SURGICAL CORP.

UNITED STATES SURGICAL CORP. is associated with 12,601 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1992 through 2005. Of the total, 40 are coded as death reports and 1,296 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 CORP. 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 11,188 reports (88.8% of total). Patient-outcome categorizations are reported across 14 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 4,845 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.

12,601
Total Reports
40
Death Reports
1,296
Injury Reports
20
Device Types

Event Types

Malfunction 11,188 (88.8%)
Injury 1,296 (10.3%)
45 (0.4%)
Death 40 (0.3%)
Other 32 (0.3%)

Patient Outcomes

11,086 (86.8%)
Other 739 (5.8%)
Required Intervention 665 (5.2%)
R 125 (1.0%)
Hospitalization 57 (0.4%)
Death 40 (0.3%)
Life Threatening 18 (0.1%)
L 10 (0.1%)
O 9 (0.1%)
Invalid Data 7 (0.1%)
S 6 (0.0%)
H 4 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Yearly Trend

92
1992: 3
93
1993: 9
94
1994: 108
95
1995: 83
96
1996: 1,581
97
1997: 4,845
98
1998: 2,568
99
1999: 1,833
00
2000: 1,382
01
2001: 156
02
2002: 1
03
2003: 11
04
2004: 9
05
2005: 12

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.