PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Instrument, Ent Manual Surgical

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §874.4420 (Ear, Nose, Throat panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Instrument, Ent Manual Surgical LIGHT-BOOK · MAUDE

#855 of 1000 · 557 reports · 2004–2026

  • BOOK 557 reports
  • RANK #855 of 1000
  • DEATH 13 death-typed
  • INJ 210 injury-typed
  • MALF 304 malfunction
  • SPAN 2004–2026
  • PEAK 2013: 53
  • PHOTO Device

Nearest event-volume peer: Device, Urine Flow Rate Measuring, Non-Electrical, Disposable (0 report gap)

Instrument, Ent Manual Surgical sits #855 of 1000 among tracked device types with 557 MAUDE reports spanning 2004–2026. 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

Instrument, Ent Manual Surgical carries 54.6% MALFUNCTION-coded reports, 10.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
  • INJ 37.7% corpus 30.3% · above corpus mean (+7.4 pp)
  • MALF 54.6% corpus 64.8% · below corpus mean (-10.2 pp)

Lead product-problem code Break is 22% of coded problems · Lead manufacturer KARL STORZ SE & CO. KG accounts for 39% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Instrument, Ent Manual Surgical in the event-volume neighbourhood

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

reports

What this shows Instrument, Ent Manual Surgical carries 557 MAUDE reports, ranked #855 of 1000.

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

Event Types

Malfunction 304 (54.6%)
Injury 210 (37.7%)
Other 23 (4.1%)
Death 13 (2.3%)
7 (1.3%)

Patient Outcomes

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

289 (46.3%)
Required Intervention 125 (20.0%)
Other 67 (10.7%)
R 38 (6.1%)
Hospitalization 36 (5.8%)
Life Threatening 21 (3.4%)
L 13 (2.1%)
Death 12 (1.9%)
O 8 (1.3%)
S 5 (0.8%)
Disability 4 (0.6%)
D 2 (0.3%)
H 2 (0.3%)
C 1 (0.2%)
Congenital Anomaly 1 (0.2%)

Top Product Problems

Break 105
Adverse Event Without Identified Device or Use Problem 81
Detachment of Device or Device Component 35
Material Separation 31
Insufficient Device Problem Information 30
Material Rupture 26
Contamination of Device Ingredient or Reagent 20
Detachment Of Device Component 19
Imprecision 19
Incorrect Interpretation of Signal 19
Material Fragmentation 18
Device Operates Differently Than Expected 14
Component Falling 10
Patient Device Interaction Problem 9
Burst Container or Vessel 8
Fracture 8
Inflation Problem 8
Improper or Incorrect Procedure or Method 7
Use of Device Problem 7
Bent 6

Yearly Trend

04
2004: 2
06
2006: 2
07
2007: 1
09
2009: 8
10
2010: 11
11
2011: 14
12
2012: 48
13
2013: 53
14
2014: 53
15
2015: 41
16
2016: 39
17
2017: 32
18
2018: 42
19
2019: 19
20
2020: 20
21
2021: 23
22
2022: 25
23
2023: 14
24
2024: 51
25
2025: 44
26
2026: 15

Reports in 2025 (44) held close to the prior two-year average of 33.

Related Entities for Instrument, Ent Manual Surgical

Top Manufacturers

KARL STORZ SE & CO. KG 55
COOK INC 46
MEDTRONIC XOMED INC. 23
WILLIAM COOK EUROPE 18

Event Locations

313 (56.2%)
I 182 (32.7%)
HOSPITAL 52 (9.3%)
NO INFORMATION 6 (1.1%)
AMBULATORY SURGICAL FACILITY 2 (0.4%)
OPERATING ROOM 1 (0.2%)
OTHER 1 (0.2%)

Compare KARL STORZ SE & CO. KG vs COOK INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument, Ent Manual Surgical: 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 (557 here).

Device 557 Needle, Suturing, Disposable 559 Prosthesis 555 Chair, Positioning, Electric 554

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Apparatus 13 Bariatric Bed 13 Chair, With Casters 13 Continuous Measurement Thermometer 13

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

Disclaimer: MAUDE figures for Instrument, Ent Manual Surgical 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 Instrument, Ent Manual Surgical; 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.