2026 data FDA MAUDE openFDA

Stapler, Surgical

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Stapler, Surgical MID-BOOK · MAUDE

#114 of 1000 · 25,936 reports · 1992–2026

  • BOOK 25,936 reports
  • RANK #114 of 1000
  • DEATH 271 death-typed
  • INJ 6,650 injury-typed
  • MALF 18,753 malfunction
  • SPAN 1992–2026
  • PEAK 1997: 3,606
  • PHOTO Device

Nearest event-volume peer: Device, Neurovascular Embolization (45 report gap)

Stapler, Surgical sits #114 of 1000 among tracked device types with 25,936 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.0% corpus 1.5% · near corpus mean (-0.5 pp)
  • INJ 25.6% corpus 30.4% · below corpus mean (-4.8 pp)
  • MALF 72.3% corpus 64.5% · above corpus mean (+7.8 pp)

Lead product-problem code Failure to Fire is 20% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, INC. accounts for 25% of manufacturer-tagged reports · Top event location NOT APPLICABLE is 39% of location-tagged rows .

Stapler, Surgical in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Stapler, Surgical carries 25,936 MAUDE reports, ranked #114 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 18,753 (72.3%)
Injury 6,650 (25.6%)
Death 271 (1.0%)
143 (0.6%)
Other 119 (0.5%)

Patient Outcomes

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

11,004 (40.5%)
Other 9,535 (35.1%)
Required Intervention 4,326 (15.9%)
R 872 (3.2%)
Hospitalization 691 (2.5%)
Death 250 (0.9%)
O 135 (0.5%)
H 95 (0.3%)
Life Threatening 69 (0.3%)
S 66 (0.2%)
L 62 (0.2%)
Disability 54 (0.2%)
Invalid Data 22 (0.1%)
Congenital Anomaly 11 (0.0%)
D 6 (0.0%)
Not Applicable 1 (0.0%)

Top Product Problems

Failure to Fire 650
Failure to Form Staple 563
Adverse Event Without Identified Device or Use Problem 401
Misfire 319
Detachment of Device or Device Component 291
Mechanics Altered 170
Difficult to Remove 168
Break 147
Failure to Align 93
Human-Device Interface Problem 71
Failure to Cut 64
Incomplete or Inadequate Connection 61
Difficult to Open or Close 50
Device Slipped 43
Mechanical Jam 42
Firing Problem 41
Material Twisted/Bent 40
Entrapment of Device 38
Retraction Problem 38
Insufficient Information 36

Yearly Trend

92
1992: 35
93
1993: 52
94
1994: 104
95
1995: 105
96
1996: 1,161
97
1997: 3,606
98
1998: 2,631
99
1999: 2,786
00
2000: 2,608
01
2001: 1,550
02
2002: 1,330
03
2003: 1,103
04
2004: 1,505
05
2005: 1,518
06
2006: 923
07
2007: 919
08
2008: 366
09
2009: 18
10
2010: 22
11
2011: 19
12
2012: 49
13
2013: 135
14
2014: 302
15
2015: 144
16
2016: 75
17
2017: 96
18
2018: 81
19
2019: 70
20
2020: 47
21
2021: 53
22
2022: 50
23
2023: 109
24
2024: 1,126
25
2025: 1,079
26
2026: 159

Related Entities for Stapler, Surgical

Event Locations

NOT APPLICABLE 10,161 (39.2%)
HOSPITAL 8,193 (31.6%)
6,423 (24.8%)
OTHER 587 (2.3%)
NO INFORMATION 204 (0.8%)
I 188 (0.7%)
INVALID DATA 121 (0.5%)
UNKNOWN 42 (0.2%)
AMBULATORY SURGICAL FACILITY 10 (0.0%)
HOME 5 (0.0%)
DIALYSIS CENTER 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ETHICON ENDO-SURGERY, INC. vs UNITED STATES SURGICAL CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stapler, Surgical, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (25,936 here).

Similar death-typed counts

Nearest other device types by death-typed report count (271 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stapler, Surgical are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Stapler, Surgical; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.