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2026 data FDA MAUDE openFDA FDA Class II

Gastroscope And Accessories, Flexible/Rigid

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 Gastroscope And Accessories, Flexible/Rigid MID-BOOK · MAUDE

#54 of 1000 · 73,278 reports · 1992–2026

  • BOOK 73,278 reports
  • RANK #54 of 1000
  • DEATH 53 death-typed
  • INJ 1,104 injury-typed
  • MALF 72,055 malfunction
  • SPAN 1992–2026
  • PEAK 2026: 24,200
  • PHOTO Glucose Dehydrogenase

Nearest event-volume peer: Glucose Dehydrogenase, Glucose (927 report gap)

Gastroscope And Accessories, Flexible/Rigid sits #54 of 1000 among tracked device types with 73,278 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 run above the device-type norm

Gastroscope And Accessories, Flexible/Rigid carries 98.3% MALFUNCTION-coded reports, 33.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 1.5% corpus 30.3% · below corpus mean (-28.8 pp)
  • MALF 98.3% corpus 64.8% · above corpus mean (+33.5 pp)

Lead product-problem code Failure to Clean Adequately is 30% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 78% of manufacturer-tagged reports · Top event location is 95% of location-tagged rows .

Gastroscope And Accessories, Flexible/Rigid in the event-volume neighbourhood

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

reports

What this shows Gastroscope And Accessories, Flexible/Rigid carries 73,278 MAUDE reports, ranked #54 of 1000.

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

Event Types

Malfunction 72,055 (98.3%)
Injury 1,104 (1.5%)
Other 58 (0.1%)
Death 53 (0.1%)
8 (0.0%)

Patient Outcomes

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

71,109 (97.2%)
Other 488 (0.7%)
Required Intervention 483 (0.7%)
Congenital Anomaly 256 (0.3%)
L 201 (0.3%)
H 170 (0.2%)
R 118 (0.2%)
Hospitalization 84 (0.1%)
Life Threatening 83 (0.1%)
O 72 (0.1%)
Death 45 (0.1%)
Disability 41 (0.1%)
D 14 (0.0%)
S 2 (0.0%)

Top Product Problems

Failure to Clean Adequately 21,848
Poor Quality Image 8,212
Communication or Transmission Problem 5,669
No Display/Image 5,601
Device Reprocessing Problem 5,463
Erratic or Intermittent Display 4,003
Residue After Decontamination 3,867
Microbial Contamination of Device 3,039
Break 2,640
Fluid/Blood Leak 2,080
Obstruction of Flow 2,032
Corroded 1,532
Contamination 1,131
Detachment of Device or Device Component 1,118
Optical Obstruction 1,069
Thermal Decomposition of Device 1,034
Melted 876
Image Display Error/Artifact 747
Contamination /Decontamination Problem 660
Overheating of Device 634

Yearly Trend

92
1992: 3
94
1994: 1
96
1996: 2
97
1997: 4
98
1998: 8
99
1999: 3
00
2000: 6
01
2001: 7
02
2002: 14
03
2003: 9
04
2004: 12
05
2005: 11
06
2006: 15
07
2007: 27
08
2008: 11
09
2009: 21
10
2010: 45
11
2011: 36
12
2012: 35
13
2013: 8
14
2014: 23
15
2015: 29
16
2016: 108
17
2017: 178
18
2018: 304
19
2019: 1,376
20
2020: 601
21
2021: 1,755
22
2022: 6,216
23
2023: 9,874
24
2024: 9,258
25
2025: 19,078
26
2026: 24,200

Reports rose to 19,078 in 2025, up from an average of 9,566 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Gastroscope And Accessories, Flexible/Rigid

Top Manufacturers

AIZU OLYMPUS CO., LTD. 56,566
HOYA CORPORATION PENTAX TOKYO OFFICE 12,616
OLYMPUS MEDICAL SYSTEMS CORP. 3,121
AOMORI OLYMPUS CO., LTD. 174
SHIRAKAWA OLYMPUS CO., LTD. 112

Event Locations

69,556 (94.9%)
I 3,353 (4.6%)
HOSPITAL 322 (0.4%)
NO INFORMATION 24 (0.0%)
AMBULATORY SURGICAL FACILITY 7 (0.0%)
OUTPATIENT TREATMENT FACILITY 6 (0.0%)
OTHER 5 (0.0%)
INVALID DATA 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)

Compare AIZU OLYMPUS CO., LTD. vs HOYA CORPORATION PENTAX TOKYO OFFICE →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Gastroscope And Accessories, Flexible/Rigid: 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 (73,278 here).

Glucose Dehydrogenase, Glucose 74,205 Set 72,142 Transcervical Contraceptive Tubal Occlusion… 74,502 System 71,804

Similar death-typed counts

Nearest other device types by death-typed report count (53 here), distinct from the volume row.

Apparatus 53 Computer, Diagnostic, Programmable 53 Prosthesis 54 Prosthesis 54

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

Disclaimer: MAUDE figures for Gastroscope And Accessories, Flexible/Rigid 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 Gastroscope And Accessories, Flexible/Rigid; 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.