What are FDA adverse event reports for Device, Endoscopic Suturing?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Device, Endoscopic Suturing, there are 843 total reports including 1 death reports and 167 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 Device, Endoscopic Suturing?

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.

2023 data FDA MAUDE openFDA

Device, Endoscopic Suturing

Name: Device, Endoscopic Suturing - 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 Device, Endoscopic Suturing LIGHT-BOOK · MAUDE

#697 of 1000 · 843 reports · 1992–2023

BOOK 843 reports
RANK #697 of 1000
DEATH 1 death-typed
INJ 167 injury-typed
MALF 638 malfunction
SPAN 1992–2023
PEAK 2000: 123
PHOTO Plate

Nearest event-volume peer: Plate, Cranioplasty, Preformed, Alterable (1 report gap)

Device, Endoscopic Suturing sits #697 of 1000 among tracked device types with 843 MAUDE reports spanning 1992–2023. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
INJ 19.8% corpus 30.4% · below corpus mean (-10.6 pp)
MALF 75.7% corpus 64.5% · above corpus mean (+11.2 pp)

Lead product-problem code Detachment Of Device Component is 25% of coded problems · Lead manufacturer NORTH HAVEN - USS accounts for 30% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Heat-Exchanger

845
Probe

844
Device (this)

843
Plate

842
Tubing

842
Vitrectomy

842

What this shows Device, Endoscopic Suturing carries 843 MAUDE reports, ranked #697 of 1000.

Event Types

Malfunction 638 (75.7%)

Injury 167 (19.8%)

Other 22 (2.6%)

15 (1.8%)

Death 1 (0.1%)

Patient Outcomes

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

441 (51.2%)

Other 307 (35.6%)

Required Intervention 76 (8.8%)

R 16 (1.9%)

Hospitalization 14 (1.6%)

Disability 3 (0.3%)

S 2 (0.2%)

O 1 (0.1%)

Death 1 (0.1%)

Life Threatening 1 (0.1%)

Yearly Trend

1992: 1

1995: 2

1996: 7

1997: 10

1998: 23

1999: 45

2000: 123

2001: 67

2002: 22

2003: 42

2004: 38

2005: 48

2006: 32

2007: 51

2008: 112

2009: 115

2010: 40

2011: 22

2012: 11

2013: 4

2014: 5

2015: 11

2016: 6

2017: 4

2018: 1

2023: 1

Top Manufacturers

NORTH HAVEN - USS 163

ETHICON ENDO-SURGERY, INC. 146

TELEFLEX MEDICAL 71

UNITED STATES SURGICAL CORP. 40

ETHICON ENDO-SURGERY, INC. (CINCINNATI) 36

ETHICON ENDO-SURGERY 32

NORTH HAVEN-USS 25

COVIDIEN 18

BOSTON SCIENTIFIC CORP. 16

Event Locations

374 (44.4%)

NOT APPLICABLE 250 (29.7%)

HOSPITAL 196 (23.3%)

I 9 (1.1%)

NO INFORMATION 4 (0.5%)

OTHER 4 (0.5%)

UNKNOWN 4 (0.5%)

AMBULATORY SURGICAL FACILITY 1 (0.1%)

INVALID DATA 1 (0.1%)

Compare NORTH HAVEN - USS vs ETHICON ENDO-SURGERY, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Device, Endoscopic Suturing, 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 (843 here).

Plate, Cranioplasty, Preformed, Alterable 842 Probe, Radiofrequency Lesion 844 Tubing, Fluid Delivery 842 Vitrectomy, Instrument Cutter 842

Similar death-typed counts

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

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Device, Endoscopic Suturing 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 Device, Endoscopic Suturing; 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.

Device, Endoscopic Suturing

Event-type mix vs corpus