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2023 data FDA MAUDE openFDA FDA Class II

Device, Endoscopic Suturing

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 §876.1500 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Device, Endoscopic Suturing LIGHT-BOOK · MAUDE

#715 of 1000 · 843 reports · 1992–2023

  • BOOK 843 reports
  • RANK #715 of 1000
  • DEATH 1 death-typed
  • INJ 167 injury-typed
  • MALF 638 malfunction
  • SPAN 1992–2023
  • PEAK 2000: 123
  • PHOTO Instruments

Nearest event-volume peer: Instruments, Surgical, Cardiovascular (2 report gap)

Device, Endoscopic Suturing sits #715 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 →

Malfunction reports run above the device-type norm

Device, Endoscopic Suturing carries 75.7% MALFUNCTION-coded reports, 10.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 19.8% corpus 30.3% · below corpus mean (-10.5 pp)
  • MALF 75.7% corpus 64.8% · above corpus mean (+10.9 pp)

Lead product-problem code Replace is 15% of coded problems · Lead manufacturer NORTH HAVEN - USS accounts for 30% of manufacturer-tagged reports · Top event location is 44% of location-tagged rows .

Device, Endoscopic Suturing in the event-volume neighbourhood

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

reports

What this shows Device, Endoscopic Suturing carries 843 MAUDE reports, ranked #715 of 1000.

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

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%)

Top Product Problems

Replace 195
Break 194
Detachment Of Device Component 174
Device, or device fragments remain in patient 103
Component(s), broken 97
Component Falling 63
Sticking 59
Device, removal of (non-implant) 52
Other (for use when an appropriate device code cannot be identified) 45
Loose 36
Tip breakage 35
Material Separation 33
Device Issue 31
Device Or Device Fragments Location Unknown 28
Difficult to Remove 27
Device Slipped 25
Bent 22
Failure to Form Staple 21
Component Missing 20
Suture line separation 20

Yearly Trend

92
1992: 1
95
1995: 2
96
1996: 7
97
1997: 10
98
1998: 23
99
1999: 45
00
2000: 123
01
2001: 67
02
2002: 22
03
2003: 42
04
2004: 38
05
2005: 48
06
2006: 32
07
2007: 51
08
2008: 112
09
2009: 115
10
2010: 40
11
2011: 22
12
2012: 11
13
2013: 4
14
2014: 5
15
2015: 11
16
2016: 6
17
2017: 4
18
2018: 1
23
2023: 1

Reports fell to 1 in 2018, down from an average of 5 in the two years before.

Related Entities for Device, Endoscopic Suturing

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 a comparable volume-and-death footprint

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

Instruments, Surgical, Cardiovascular 845 Dislodger, Stone, Biliary 847 Incubator, Neonatal 847 Posterior Metal/Polymer Spinal System 848

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.