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2026 data FDA MAUDE openFDA FDA Class II

Enteroscope 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 §876.1500 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Enteroscope And Accessories LIGHT-BOOK · MAUDE

#736 of 1000 · 796 reports · 2002–2026

  • BOOK 796 reports
  • RANK #736 of 1000
  • DEATH 10 death-typed
  • INJ 332 injury-typed
  • MALF 449 malfunction
  • SPAN 2002–2026
  • PEAK 2026: 166
  • PHOTO Scissors

Nearest event-volume peer: Scissors, General, Surgical (1 report gap)

Enteroscope And Accessories sits #736 of 1000 among tracked device types with 796 MAUDE reports spanning 2002–2026. 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 →

Injury-coded reports run above the device-type norm

Enteroscope And Accessories carries 41.7% INJURY-coded reports, 11.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 41.7% corpus 30.3% · above corpus mean (+11.4 pp)
  • MALF 56.4% corpus 64.8% · below corpus mean (-8.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 31% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 56% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Enteroscope And Accessories in the event-volume neighbourhood

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

reports

What this shows Enteroscope And Accessories carries 796 MAUDE reports, ranked #736 of 1000.

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

Event Types

Malfunction 449 (56.4%)
Injury 332 (41.7%)
Death 10 (1.3%)
3 (0.4%)
Other 2 (0.3%)

Patient Outcomes

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

443 (53.1%)
Other 247 (29.6%)
Required Intervention 63 (7.6%)
R 24 (2.9%)
Hospitalization 21 (2.5%)
O 15 (1.8%)
Death 10 (1.2%)
H 9 (1.1%)
D 2 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 227
Failure to Clean Adequately 158
Appropriate Device Problem Term/Code Not Available 54
Microbial Contamination of Device 46
Insufficient Device Problem Information 36
Device Reprocessing Problem 32
No Display/Image 23
Poor Quality Image 21
Erratic or Intermittent Display 16
Contamination 15
Loss of or Failure to Bond 12
Premature Separation 12
Corroded 11
Melted 11
Residue After Decontamination 11
Device Operates Differently Than Expected 10
Pressure Problem 9
Inflation Problem 8
Mechanical Problem 7
Overheating of Device 7

Yearly Trend

02
2002: 4
05
2005: 2
06
2006: 2
07
2007: 1
08
2008: 1
09
2009: 3
10
2010: 1
12
2012: 2
13
2013: 2
14
2014: 3
15
2015: 2
16
2016: 5
17
2017: 28
18
2018: 81
19
2019: 76
20
2020: 29
21
2021: 24
22
2022: 87
23
2023: 72
24
2024: 86
25
2025: 119
26
2026: 166

Reports rose to 119 in 2025, up from an average of 79 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Enteroscope And Accessories

Top Manufacturers

AIZU OLYMPUS CO., LTD. 397
OLYMPUS MEDICAL SYSTEMS CORP. 255
SHIRAKAWA OLYMPUS CO., LTD. 16
UNOMEDICAL DEVICES S.A DE C.V 14
CAREFUSION SD 9
MEDLINE INDUSTRIES, LP 9
UNOMEDICAL A/S 9

Event Locations

540 (67.8%)
I 220 (27.6%)
HOSPITAL 31 (3.9%)
NO INFORMATION 3 (0.4%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
OTHER 1 (0.1%)

Compare AIZU OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Enteroscope And Accessories: 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 (796 here).

Scissors, General, Surgical 795 Electrode, Electrosurgical 798 Heparin, Vascular Access Flush 800 Tray 800

Similar death-typed counts

Nearest other device types by death-typed report count (10 here), distinct from the volume row.

Accessories, Catheter 10 Adaptor, Hygiene 10 Blood Pump For Ecmo, Long-Term Use 10 Chair, Adjustable, Mechanical 10

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

Disclaimer: MAUDE figures for Enteroscope And Accessories 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 Enteroscope And Accessories; 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.