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2026 data FDA MAUDE openFDA FDA Class II

Coagulator-Cutter, Endoscopic, Unipolar (And 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 §884.4160 (Obstetrics/Gynecology panel).

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FDA MAUDE casebook

openFDA event book Coagulator-Cutter, Endoscopic, Unipolar LIGHT-BOOK · MAUDE

#965 of 1000 · 404 reports · 1992–2026

  • BOOK 404 reports
  • RANK #965 of 1000
  • DEATH 0 death-typed
  • INJ 164 injury-typed
  • MALF 211 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 94
  • PHOTO Camera, Scintillation

Nearest event-volume peer: Camera, Scintillation (Gamma) (0 report gap)

Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) sits #965 of 1000 among tracked device types with 404 MAUDE reports spanning 1992–2026. 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 sit below the device-type norm

Coagulator-Cutter, Endoscopic, Unipolar carries 52.2% MALFUNCTION-coded reports, 12.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 40.6% corpus 30.3% · above corpus mean (+10.3 pp)
  • MALF 52.2% corpus 64.8% · below corpus mean (-12.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer KARL STORZ SE & CO. KG accounts for 79% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Coagulator-Cutter, Endoscopic, Unipolar in the event-volume neighbourhood

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

reports

What this shows Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) carries 404 MAUDE reports, ranked #965 of 1000.

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

Event Types

Malfunction 211 (52.2%)
Injury 164 (40.6%)
Other 24 (5.9%)
5 (1.2%)

Patient Outcomes

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

186 (40.0%)
Other 93 (20.0%)
Required Intervention 88 (18.9%)
Hospitalization 34 (7.3%)
H 28 (6.0%)
R 27 (5.8%)
O 5 (1.1%)
Life Threatening 2 (0.4%)
L 1 (0.2%)
S 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 91
Break 86
Material Separation 28
Detachment of Device or Device Component 20
Fire 19
Thermal Decomposition of Device 19
Sparking 17
Replace 15
Intraprocedure, fire or flash during 10
Smoking 10
Insufficient Device Problem Information 9
Material Fragmentation 9
Detachment Of Device Component 8
Failure to Cut 8
Melted 8
Tip breakage 6
Difficult to Remove 5
Fracture 5
Improper or Incorrect Procedure or Method 5
Material Twisted/Bent 5

Yearly Trend

92
1992: 1
94
1994: 1
95
1995: 3
96
1996: 4
97
1997: 6
98
1998: 17
99
1999: 6
00
2000: 21
01
2001: 1
02
2002: 2
03
2003: 2
04
2004: 1
06
2006: 3
08
2008: 2
09
2009: 1
10
2010: 14
11
2011: 16
12
2012: 4
13
2013: 24
14
2014: 8
15
2015: 7
16
2016: 9
17
2017: 22
18
2018: 13
19
2019: 18
20
2020: 19
21
2021: 9
22
2022: 16
23
2023: 33
24
2024: 13
25
2025: 94
26
2026: 14

Reports rose to 94 in 2025, up from an average of 23 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Top Manufacturers

KARL STORZ SE & CO. KG 63
AESCULAP AG 9
AESCULAP AG 8

Event Locations

240 (59.4%)
I 79 (19.6%)
HOSPITAL 72 (17.8%)
AMBULATORY SURGICAL FACILITY 5 (1.2%)
NO INFORMATION 4 (1.0%)
OTHER 2 (0.5%)
INVALID DATA 1 (0.2%)
NOT APPLICABLE 1 (0.2%)

Compare KARL STORZ SE & CO. KG vs AESCULAP AG →

Nationwide devices with a comparable report-volume footprint

Coagulator-Cutter, Endoscopic, Unipolar carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (404 here).

Camera, Scintillation 404 Methyl Methacrylate For Cranioplasty 403 Stimulator, Thalamic, Epilepsy, Implanted 403 Enteral Specific Transition Connectors 402

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Coagulator-Cutter, Endoscopic, Unipolar 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 Coagulator-Cutter, Endoscopic, Unipolar; 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.