2026 data FDA MAUDE openFDA FDA Class II

Ligator, Esophageal

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 §876.4400 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Ligator, Esophageal MID-BOOK · MAUDE

#207 of 1000 · 10,683 reports · 1993–2026

  • BOOK 10,683 reports
  • RANK #207 of 1000
  • DEATH 71 death-typed
  • INJ 935 injury-typed
  • MALF 9,656 malfunction
  • SPAN 1993–2026
  • PEAK 2009: 1,161
  • PHOTO Walker, Mechanical

Nearest event-volume peer: Walker, Mechanical (10 report gap)

Ligator, Esophageal sits #207 of 1000 among tracked device types with 10,683 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

Ligator, Esophageal carries 90.4% MALFUNCTION-coded reports, 25.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 8.8% corpus 30.3% · below corpus mean (-21.5 pp)
  • MALF 90.4% corpus 64.8% · above corpus mean (+25.6 pp)

Lead product-problem code Failure to Fire is 30% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 55% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

Ligator, Esophageal in the event-volume neighbourhood

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

reports

What this shows Ligator, Esophageal carries 10,683 MAUDE reports, ranked #207 of 1000.

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

Event Types

Malfunction 9,656 (90.4%)
Injury 935 (8.8%)
Death 71 (0.7%)
14 (0.1%)
Other 7 (0.1%)

Patient Outcomes

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

9,549 (88.7%)
Required Intervention 708 (6.6%)
Other 182 (1.7%)
Hospitalization 123 (1.1%)
R 89 (0.8%)
Death 66 (0.6%)
O 20 (0.2%)
H 16 (0.1%)
L 7 (0.1%)
Life Threatening 3 (0.0%)
D 2 (0.0%)
Disability 2 (0.0%)
S 1 (0.0%)

Top Product Problems

Failure to Fire 3,527
Premature Activation 1,146
Positioning Failure 1,009
Separation Failure 964
Break 779
Use of Device Problem 462
Detachment Of Device Component 451
Adverse Event Without Identified Device or Use Problem 445
Material Separation 333
Failure to Advance 306
Material Integrity Problem 286
Failure to Disconnect 280
Difficult or Delayed Positioning 261
Other (for use when an appropriate device code cannot be identified) 255
Misfire 216
Detachment of Device or Device Component 210
Activation, Positioning or Separation Problem 201
Device Dislodged or Dislocated 155
Human-Device Interface Problem 144
Difficult or Delayed Separation 143

Yearly Trend

93
1993: 2
94
1994: 3
96
1996: 6
97
1997: 9
98
1998: 4
99
1999: 5
00
2000: 9
01
2001: 38
02
2002: 64
03
2003: 76
04
2004: 66
05
2005: 47
06
2006: 92
07
2007: 84
08
2008: 451
09
2009: 1,161
10
2010: 600
11
2011: 672
12
2012: 719
13
2013: 750
14
2014: 117
15
2015: 76
16
2016: 94
17
2017: 88
18
2018: 124
19
2019: 294
20
2020: 345
21
2021: 674
22
2022: 808
23
2023: 689
24
2024: 921
25
2025: 1,098
26
2026: 497

Reports in 2025 (1,098) held close to the prior two-year average of 805.

Related Entities for Ligator, Esophageal

Event Locations

8,467 (79.3%)
I 1,212 (11.3%)
HOSPITAL 899 (8.4%)
NO INFORMATION 42 (0.4%)
OUTPATIENT DIAGNOSTIC FACILITY 36 (0.3%)
OUTPATIENT TREATMENT FACILITY 10 (0.1%)
AMBULATORY SURGICAL FACILITY 6 (0.1%)
OTHER 6 (0.1%)
INVALID DATA 2 (0.0%)
NOT APPLICABLE 2 (0.0%)
UNKNOWN 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - MARLBOROUGH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ligator, Esophageal: 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 (10,683 here).

Similar death-typed counts

Nearest other device types by death-typed report count (71 here), distinct from the volume row.

Disclaimer: MAUDE figures for Ligator, Esophageal 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 Ligator, Esophageal; 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.