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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#155 of 1000 · 16,529 reports · 1994–2026

  • BOOK 16,529 reports
  • RANK #155 of 1000
  • DEATH 73 death-typed
  • INJ 3,316 injury-typed
  • MALF 12,953 malfunction
  • SPAN 1994–2026
  • PEAK 2024: 1,532
  • PHOTO Drills

Nearest event-volume peer: Drills, Burrs, Trephines & Accessories (Simple, Powered) (7 report gap)

Unit, Electrosurgical, Endoscopic (With Or Without Accessories) sits #155 of 1000 among tracked device types with 16,529 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 →

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 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 20.1% corpus 30.4% · below corpus mean (-10.4 pp)
  • MALF 78.4% corpus 64.5% · above corpus mean (+13.9 pp)

Lead product-problem code Break is 41% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 36% of manufacturer-tagged reports · Top event location is 63% 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 16,529 MAUDE reports, ranked #155 of 1000.

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

Event Types

Malfunction 12,953 (78.4%)
Injury 3,316 (20.1%)
Other 144 (0.9%)
Death 73 (0.4%)
43 (0.3%)

Patient Outcomes

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

12,244 (71.1%)
Other 2,152 (12.5%)
Required Intervention 1,651 (9.6%)
R 399 (2.3%)
Hospitalization 354 (2.1%)
O 154 (0.9%)
H 113 (0.7%)
Death 63 (0.4%)
L 26 (0.2%)
Disability 19 (0.1%)
Life Threatening 18 (0.1%)
D 14 (0.1%)
S 5 (0.0%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Break 3,840
Adverse Event Without Identified Device or Use Problem 2,174
Detachment of Device or Device Component 483
Failure to Align 427
Material Separation 324
Material Deformation 288
Use of Device Problem 211
Positioning Problem 198
Failure to Deliver Energy 195
Material Split, Cut or Torn 176
Peeled/Delaminated 174
Off-Label Use 121
Device Dislodged or Dislocated 119
Retraction Problem 116
Failure to Conduct 92
Mechanical Problem 89
Material Twisted/Bent 86
Device Contamination with Chemical or Other Material 83
Material Integrity Problem 81
Activation Failure 78

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: 913
11
2011: 859
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: 1,532
25
2025: 1,525
26
2026: 207

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

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 4,517
AOMORI OLYMPUS CO., LTD. 2,006
OLYMPUS MEDICAL SYSTEMS CORP. 1,514
COOK ENDOSCOPY 1,427
BOSTON SCIENTIFIC - SPENCER 972
WILSON-COOK MEDICAL INC 626
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 562
BOSTON SCIENTIFIC - MARLBOROUGH 532
WILSON-COOK MEDICAL INC. 360

Event Locations

10,401 (62.9%)
I 3,063 (18.5%)
HOSPITAL 1,925 (11.6%)
NOT APPLICABLE 795 (4.8%)
OTHER 201 (1.2%)
NO INFORMATION 68 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Unit, Electrosurgical, Endoscopic, 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 (16,529 here).

Drills, Burrs, Trephines & Accessories 16,522 Dc-Defibrillator, Low-Energy, 16,560 Aligner, Sequential 16,486 Catheter, Urological 16,473

Similar death-typed counts

Nearest other device types by death-typed report count (73 here), distinct from the volume row.

Transmitters And Receivers 73 Catheter, Hemodialysis, Non-Implanted 72 Catheter, Ultrasound, Intravascular 72 Intestinal Stimulator 72

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.