What are FDA adverse event reports for Staple, Implantable?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Staple, Implantable, there are 164,903 total reports including 1,085 death reports and 31,194 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Staple, Implantable?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Staple, Implantable

Name: Staple, Implantable - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

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

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Staple, Implantable HEAVY-BOOK · MAUDE

#23 of 1000 · 164,903 reports · 1993–2026

BOOK 164,903 reports
RANK #23 of 1000
DEATH 1,085 death-typed
INJ 31,194 injury-typed
MALF 132,068 malfunction
SPAN 1993–2026
PEAK 2019: 16,600
PHOTO Defibrillator

Nearest event-volume peer: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) (49 report gap)

Staple, Implantable sits #23 of 1000 among tracked device types with 164,903 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 →

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 0.7% corpus 1.5% · below corpus mean (-0.9 pp)
INJ 18.9% corpus 30.4% · below corpus mean (-11.5 pp)
MALF 80.1% corpus 64.5% · above corpus mean (+15.6 pp)

Lead product-problem code Failure to Fire is 31% of coded problems · Lead manufacturer ETHICON ENDO-SURGERY, LLC. accounts for 41% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Mesh

168,757
Defibrillator

164,952
Staple (this)

164,903
System

163,240
Prosthesis

153,958
Ventricular B…

153,365

What this shows Staple, Implantable carries 164,903 MAUDE reports, ranked #23 of 1000.

Event Types

Malfunction 132,068 (80.1%)

Injury 31,194 (18.9%)

Death 1,085 (0.7%)

327 (0.2%)

Other 229 (0.1%)

Patient Outcomes

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

132,840 (77.2%)

Required Intervention 19,025 (11.1%)

Other 7,106 (4.1%)

R 4,682 (2.7%)

Hospitalization 3,479 (2.0%)

Disability 1,075 (0.6%)

O 927 (0.5%)

Death 904 (0.5%)

H 800 (0.5%)

S 606 (0.4%)

Life Threatening 257 (0.1%)

L 251 (0.1%)

D 136 (0.1%)

Congenital Anomaly 8 (0.0%)

Yearly Trend

1993: 4

1994: 8

1995: 13

1996: 5

1997: 2

1999: 4

2000: 6

2001: 15

2002: 54

2003: 172

2004: 318

2005: 411

2006: 1,203

2007: 2,400

2008: 2,380

2009: 4,014

2010: 3,769

2011: 3,828

2012: 3,717

2013: 3,777

2014: 4,784

2015: 4,899

2016: 5,106

2017: 11,643

2018: 14,914

2019: 16,600

2020: 12,332

2021: 13,015

2022: 13,605

2023: 14,623

2024: 13,280

2025: 12,056

2026: 1,946

Top Manufacturers

ETHICON ENDO-SURGERY, LLC. 58,098

COVIDIEN LP LLC NORTH HAVEN 38,931

US SURGICAL PUERTO RICO 33,241

ETHICON ENDO-SURGERY, LLC 3,584

COVIDIEN 2,765

COVIDIEN SURGICAL 2,434

INTUITIVE SURGICAL, INC 2,010

ETHICON ENDO-SURGERY, INC. (CINCINNATI) 1,552

Event Locations

83,313 (50.5%)

I 70,486 (42.7%)

OTHER 5,176 (3.1%)

HOSPITAL 3,377 (2.0%)

NOT APPLICABLE 1,745 (1.1%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Staple, Implantable, 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 (164,903 here).

Defibrillator 164,952 System, Peritoneal, Automatic Delivery 163,240 Mesh, Surgical, Polymeric 168,757 Prosthesis 153,958

Similar death-typed counts

Nearest other device types by death-typed report count (1,085 here), distinct from the volume row.

Leadless Pacemaker 1,149 Automated Insulin Dosing Device System 1,227 Dc-Defibrillator, Low-Energy, 942 Filter, Intravascular, Cardiovascular 928

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.

Staple, Implantable

Event-type mix vs corpus