PlainHospital
2026 data FDA MAUDE openFDA

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Enteroscope And Accessories LIGHT-BOOK · MAUDE

#776 of 1000 · 665 reports · 2002–2026

  • BOOK 665 reports
  • RANK #776 of 1000
  • DEATH 10 death-typed
  • INJ 329 injury-typed
  • MALF 321 malfunction
  • SPAN 2002–2026
  • PEAK 2025: 119
  • PHOTO Injector, Pen

Nearest event-volume peer: Injector, Pen (0 report gap)

Enteroscope And Accessories sits #776 of 1000 among tracked device types with 665 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 →

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 1.5% corpus 1.5% · near corpus mean (-0.0 pp)
  • INJ 49.5% corpus 30.4% · above corpus mean (+19.0 pp)
  • MALF 48.3% corpus 64.5% · below corpus mean (-16.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 37% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 53% of manufacturer-tagged reports · Top event location is 62% 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 665 MAUDE reports, ranked #776 of 1000.

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

Event Types

Injury 329 (49.5%)
Malfunction 321 (48.3%)
Death 10 (1.5%)
3 (0.5%)
Other 2 (0.3%)

Patient Outcomes

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

335 (46.9%)
Other 236 (33.1%)
Required Intervention 63 (8.8%)
R 23 (3.2%)
Hospitalization 21 (2.9%)
O 15 (2.1%)
Death 10 (1.4%)
H 9 (1.3%)
D 2 (0.3%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 221
Failure to Clean Adequately 131
Microbial Contamination of Device 44
Appropriate Term/Code Not Available 43
Insufficient Information 32
Device Reprocessing Problem 27
Contamination 15
No Display/Image 11
Device Operates Differently Than Expected 10
Erratic or Intermittent Display 8
Inflation Problem 7
Mechanical Problem 7
Poor Quality Image 7
Pressure Problem 7
Corroded 6
Crack 6
Break 5
Flare or Flash 5
Residue After Decontamination 5
Detachment of Device or Device Component 4

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: 35

Related Entities for Enteroscope And Accessories

Top Manufacturers

AIZU OLYMPUS CO., LTD. 306
OLYMPUS MEDICAL SYSTEMS CORP. 255
SHIRAKAWA OLYMPUS CO., LTD. 12
CAREFUSION SD 9

Event Locations

411 (61.8%)
I 220 (33.1%)
HOSPITAL 29 (4.4%)
NO INFORMATION 3 (0.5%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
OTHER 1 (0.2%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Enteroscope And Accessories, 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 (665 here).

Injector, Pen 665 Endoscope, Ac-Powered And Accessories 664 Forceps, General & Plastic Surgery 664 Accessories, Photographic, For Endoscope 667

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 Cabinet, Table And Tray, Anesthesia 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.