2026 data FDA MAUDE openFDA FDA Class II

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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 §878.4400 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Electrosurgical LIGHT-BOOK · MAUDE

#747 of 1000 · 772 reports · 2005–2026

  • BOOK 772 reports
  • RANK #747 of 1000
  • DEATH 2 death-typed
  • INJ 131 injury-typed
  • MALF 635 malfunction
  • SPAN 2005–2026
  • PEAK 2013: 161
  • PHOTO Adhesive

Nearest event-volume peer: Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt (1 report gap)

Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed sits #747 of 1000 among tracked device types with 772 MAUDE reports spanning 2005–2026. 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 → · Similar-volume device →

Malfunction reports run above the device-type norm

Electrosurgical carries 82.3% MALFUNCTION-coded reports, 17.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 17.0% corpus 30.3% · below corpus mean (-13.3 pp)
  • MALF 82.3% corpus 64.8% · above corpus mean (+17.4 pp)

Lead product-problem code Difficult to Open or Close is 15% of coded problems · Top event location is 65% of location-tagged rows .

Electrosurgical in the event-volume neighbourhood

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

reports

What this shows Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed carries 772 MAUDE reports, ranked #747 of 1000.

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

Event Types

Malfunction 635 (82.3%)
Injury 131 (17.0%)
3 (0.4%)
Death 2 (0.3%)
Other 1 (0.1%)

Patient Outcomes

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

655 (84.3%)
Required Intervention 70 (9.0%)
Other 39 (5.0%)
R 5 (0.6%)
Hospitalization 4 (0.5%)
Death 2 (0.3%)
H 1 (0.1%)
L 1 (0.1%)

Top Product Problems

Difficult to Open or Close 98
Energy Output Problem 81
Device Operates Differently Than Expected 76
Failure to Cut 51
Use of Device Problem 46
Break 39
Detachment of Device or Device Component 35
Sticking 34
Mechanics Altered 26
Failure to Seal 25
Mechanical Jam 22
Output Problem 17
Device Inoperable 16
Failure To Adhere Or Bond 16
Activation Problem 15
Dull, Blunt 14
Activation Failure 13
Detachment Of Device Component 12
Retraction Problem 10
Energy Output To Patient Tissue Incorrect 9

Yearly Trend

05
2005: 4
06
2006: 1
07
2007: 4
08
2008: 4
09
2009: 1
10
2010: 9
11
2011: 2
12
2012: 39
13
2013: 161
14
2014: 74
15
2015: 25
16
2016: 52
17
2017: 51
18
2018: 14
19
2019: 20
20
2020: 59
21
2021: 47
22
2022: 31
23
2023: 27
24
2024: 92
25
2025: 38
26
2026: 17

Reports fell to 38 in 2025, down from an average of 60 in the two years before.

Related Entities for Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

Event Locations

505 (65.4%)
I 205 (26.6%)
HOSPITAL 48 (6.2%)
NO INFORMATION 14 (1.8%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Electrosurgical: 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 (772 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Electrosurgical 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 Electrosurgical; 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.