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2026 data FDA MAUDE openFDA FDA Class II

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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 §876.4300 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Unit, Electrosurgical, Endoscopic MID-BOOK · MAUDE

#156 of 1000 · 17,379 reports · 1994–2026

  • BOOK 17,379 reports
  • RANK #156 of 1000
  • DEATH 81 death-typed
  • INJ 3,644 injury-typed
  • MALF 13,467 malfunction
  • SPAN 1994–2026
  • PEAK 2024: 1,533
  • PHOTO Console

Nearest event-volume peer: Console, Heart-Lung Machine, Cardiopulmonary Bypass (91 report gap)

Unit, Electrosurgical, Endoscopic (With Or Without Accessories) sits #156 of 1000 among tracked device types with 17,379 MAUDE reports spanning 1994–2026. 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

Unit, Electrosurgical, Endoscopic carries 77.5% MALFUNCTION-coded reports, 12.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 21.0% corpus 30.3% · below corpus mean (-9.3 pp)
  • MALF 77.5% corpus 64.8% · above corpus mean (+12.7 pp)

Lead product-problem code Break is 34% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 39% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Unit, Electrosurgical, Endoscopic in the event-volume neighbourhood

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

reports

What this shows Unit, Electrosurgical, Endoscopic (With Or Without Accessories) carries 17,379 MAUDE reports, ranked #156 of 1000.

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

Event Types

Malfunction 13,467 (77.5%)
Injury 3,644 (21.0%)
Other 144 (0.8%)
Death 81 (0.5%)
43 (0.2%)

Patient Outcomes

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

12,716 (70.4%)
Other 2,331 (12.9%)
Required Intervention 1,734 (9.6%)
R 427 (2.4%)
Hospitalization 381 (2.1%)
O 179 (1.0%)
H 133 (0.7%)
Death 65 (0.4%)
L 30 (0.2%)
Disability 19 (0.1%)
Life Threatening 19 (0.1%)
D 15 (0.1%)
S 5 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Break 4,928
Adverse Event Without Identified Device or Use Problem 2,661
Failure to Align 788
Failure to Deliver Energy 717
Replace 597
Detachment of Device or Device Component 556
Material Separation 552
Detachment Of Device Component 442
Other (for use when an appropriate device code cannot be identified) 407
Retraction Problem 394
Positioning Problem 324
Material Deformation 300
Use of Device Problem 295
Tip breakage 288
Peeled/Delaminated 274
Malposition of Device 256
Bent 248
Failure to Conduct 221
Wire(s), breakage of 218
Electrical /Electronic Property Problem 217

Yearly Trend

94
1994: 9
95
1995: 12
96
1996: 57
97
1997: 287
98
1998: 248
99
1999: 169
00
2000: 169
01
2001: 228
02
2002: 88
03
2003: 118
04
2004: 139
05
2005: 175
06
2006: 168
07
2007: 164
08
2008: 587
09
2009: 1,024
10
2010: 912
11
2011: 860
12
2012: 848
13
2013: 449
14
2014: 405
15
2015: 406
16
2016: 457
17
2017: 446
18
2018: 563
19
2019: 668
20
2020: 906
21
2021: 814
22
2022: 913
23
2023: 976
24
2024: 1,533
25
2025: 1,523
26
2026: 1,058

Reports in 2025 (1,523) held close to the prior two-year average of 1,255.

Related Entities for Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 5,154
AOMORI OLYMPUS CO., LTD. 2,063
OLYMPUS MEDICAL SYSTEMS CORP. 1,516
COOK ENDOSCOPY 1,426
BOSTON SCIENTIFIC - SPENCER 972
WILSON-COOK MEDICAL INC 650
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 562
BOSTON SCIENTIFIC - MARLBOROUGH 532
WILSON-COOK MEDICAL INC. 360

Event Locations

11,244 (64.7%)
I 3,061 (17.6%)
HOSPITAL 1,935 (11.1%)
NOT APPLICABLE 795 (4.6%)
OTHER 201 (1.2%)
NO INFORMATION 67 (0.4%)
UNKNOWN 22 (0.1%)
AMBULATORY SURGICAL FACILITY 21 (0.1%)
INVALID DATA 21 (0.1%)
OUTPATIENT TREATMENT FACILITY 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.0%)
HOME 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs AOMORI OLYMPUS CO., LTD. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Unit, Electrosurgical, Endoscopic: 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 (17,379 here).

Console 17,288 System, Appendage Closure, Left Atrial 17,177 Implant, Intragastric For Morbid Obesity 17,663 Fastener 17,071

Similar death-typed counts

Nearest other device types by death-typed report count (81 here), distinct from the volume row.

Instrument, Ultrasonic Surgical 81 Tubing, Pump, Cardiopulmonary Bypass 81 Apparatus, Autotransfusion 82 Device, Monitoring, Intracranial Pressure 82

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

Disclaimer: MAUDE figures for Unit, Electrosurgical, Endoscopic 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 Unit, Electrosurgical, Endoscopic; 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.