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2026 data FDA MAUDE openFDA FDA Class II

Staple, Implantable

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 Class II (moderate risk, special controls required), regulated under 21 CFR §878.4750 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Staple, Implantable HEAVY-BOOK · MAUDE

#22 of 1000 · 169,612 reports · 1993–2026

  • BOOK 169,612 reports
  • RANK #22 of 1000
  • DEATH 1,100 death-typed
  • INJ 31,855 injury-typed
  • MALF 136,100 malfunction
  • SPAN 1993–2026
  • PEAK 2019: 16,600
  • PHOTO Defibrillator

Nearest event-volume peer: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (39 report gap)

Staple, Implantable sits #22 of 1000 among tracked device types with 169,612 MAUDE reports spanning 1993–2026. 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 →

Malfunction reports run above the device-type norm

Staple, Implantable carries 80.2% MALFUNCTION-coded reports, 15.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 18.8% corpus 30.3% · below corpus mean (-11.5 pp)
  • MALF 80.2% corpus 64.8% · above corpus mean (+15.4 pp)

Lead product-problem code Failure to Fire is 27% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, LLC. accounts for 41% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Staple, Implantable in the event-volume neighbourhood

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

reports

What this shows Staple, Implantable carries 169,612 MAUDE reports, ranked #22 of 1000.

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

Event Types

Malfunction 136,100 (80.2%)
Injury 31,855 (18.8%)
Death 1,100 (0.6%)
327 (0.2%)
Other 230 (0.1%)

Patient Outcomes

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

136,522 (77.3%)
Required Intervention 19,517 (11.0%)
Other 7,222 (4.1%)
R 4,746 (2.7%)
Hospitalization 3,576 (2.0%)
Disability 1,077 (0.6%)
O 930 (0.5%)
Death 913 (0.5%)
H 868 (0.5%)
S 606 (0.3%)
Life Threatening 260 (0.1%)
L 253 (0.1%)
D 140 (0.1%)
Congenital Anomaly 8 (0.0%)

Top Product Problems

Failure to Fire 50,795
Failure to Form Staple 34,805
Difficult to Open or Close 16,471
Misfire 15,395
Adverse Event Without Identified Device or Use Problem 11,847
Break 8,320
Entrapment of Device 5,481
Insufficient Device Problem Information 4,937
Failure to Cut 4,146
Human-Device Interface Problem 4,043
Detachment of Device or Device Component 4,031
Mechanical Jam 3,991
Device Operates Differently Than Expected 3,959
Noise, Audible 3,903
Replace 3,829
Difficult to Remove 2,849
Firing Problem 2,696
Mechanics Altered 2,407
Sticking 2,098
Detachment Of Device Component 2,096

Yearly Trend

93
1993: 4
94
1994: 8
95
1995: 13
96
1996: 5
97
1997: 2
99
1999: 4
00
2000: 6
01
2001: 15
02
2002: 54
03
2003: 172
04
2004: 318
05
2005: 411
06
2006: 1,203
07
2007: 2,400
08
2008: 2,381
09
2009: 4,014
10
2010: 3,768
11
2011: 3,826
12
2012: 3,718
13
2013: 3,777
14
2014: 4,784
15
2015: 4,899
16
2016: 5,106
17
2017: 11,643
18
2018: 14,914
19
2019: 16,600
20
2020: 12,332
21
2021: 13,015
22
2022: 13,605
23
2023: 14,623
24
2024: 13,280
25
2025: 12,053
26
2026: 6,659

Reports in 2025 (12,053) held close to the prior two-year average of 13,952.

Related Entities for Staple, Implantable

Top Manufacturers

ETHICON ENDO-SURGERY, LLC. 59,887
COVIDIEN LP LLC NORTH HAVEN 38,926
US SURGICAL PUERTO RICO 33,235
COVIDIEN SURGICAL 3,703
COVIDIEN 3,676
ETHICON ENDO-SURGERY, LLC 3,608
INTUITIVE SURGICAL, INC 2,242
ETHICON ENDO-SURGERY, INC. (CINCINNATI) 1,552

Event Locations

87,987 (51.9%)
I 70,484 (41.6%)
OTHER 5,176 (3.1%)
HOSPITAL 3,414 (2.0%)
NOT APPLICABLE 1,745 (1.0%)
NO INFORMATION 766 (0.5%)
AMBULATORY SURGICAL FACILITY 9 (0.0%)
OPERATING ROOM 9 (0.0%)
INVALID DATA 7 (0.0%)
OUTPATIENT TREATMENT FACILITY 5 (0.0%)
HOME 4 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 3 (0.0%)
UNKNOWN 2 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)

Compare ETHICON ENDO-SURGERY, LLC. vs COVIDIEN LP LLC NORTH HAVEN →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Staple, Implantable: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (169,612 here).

Defibrillator 169,573 Mesh, Surgical, Polymeric 170,120 Integrated Continuous Glucose Monitoring Sy… 165,468 System, Peritoneal, Automatic Delivery 164,500

Similar death-typed counts

Nearest other device types by death-typed report count (1,100 here), distinct from the volume row.

Automated Insulin Dosing Device System 1,254 Dc-Defibrillator, Low-Energy, 943 Leadless Pacemaker 1,257 Filter, Intravascular, Cardiovascular 929

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Staple, Implantable 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 Staple, Implantable; 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.