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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#61 of 1000 · 56,447 reports · 1992–2026

  • BOOK 56,447 reports
  • RANK #61 of 1000
  • DEATH 53 death-typed
  • INJ 1,079 injury-typed
  • MALF 55,249 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 19,078
  • PHOTO Screw, Fixation, Bone

Nearest event-volume peer: Screw, Fixation, Bone (519 report gap)

Gastroscope And Accessories, Flexible/Rigid sits #61 of 1000 among tracked device types with 56,447 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 1.9% corpus 30.4% · below corpus mean (-28.5 pp)
  • MALF 97.9% corpus 64.5% · above corpus mean (+33.4 pp)

Lead product-problem code Failure to Clean Adequately is 33% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 72% of manufacturer-tagged reports · Top event location is 93% 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 56,447 MAUDE reports, ranked #61 of 1000.

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

Event Types

Malfunction 55,249 (97.9%)
Injury 1,079 (1.9%)
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.

54,703 (96.4%)
Other 481 (0.8%)
Required Intervention 469 (0.8%)
Congenital Anomaly 256 (0.5%)
L 199 (0.4%)
H 170 (0.3%)
R 118 (0.2%)
Life Threatening 83 (0.1%)
Hospitalization 81 (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 18,354
Poor Quality Image 6,008
Device Reprocessing Problem 4,050
No Display/Image 3,561
Communication or Transmission Problem 3,037
Microbial Contamination of Device 2,792
Break 2,551
Erratic or Intermittent Display 2,499
Fluid/Blood Leak 2,022
Residue After Decontamination 2,005
Obstruction of Flow 1,948
Contamination 1,058
Detachment of Device or Device Component 1,040
Optical Obstruction 1,037
Thermal Decomposition of Device 748
Corroded 710
Melted 624
Contamination /Decontamination Problem 601
Adverse Event Without Identified Device or Use Problem 585
Device Contamination with Chemical or Other Material 530

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: 7,369

Related Entities for Gastroscope And Accessories, Flexible/Rigid

Top Manufacturers

AIZU OLYMPUS CO., LTD. 39,995
HOYA CORPORATION PENTAX TOKYO OFFICE 12,410
OLYMPUS MEDICAL SYSTEMS CORP. 3,119
AOMORI OLYMPUS CO., LTD. 162
SHIRAKAWA OLYMPUS CO., LTD. 103

Event Locations

52,734 (93.4%)
I 3,353 (5.9%)
HOSPITAL 315 (0.6%)
NO INFORMATION 24 (0.0%)
AMBULATORY SURGICAL FACILITY 6 (0.0%)
OUTPATIENT TREATMENT FACILITY 6 (0.0%)
OTHER 5 (0.0%)
INVALID DATA 3 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Gastroscope And Accessories, Flexible/Rigid, 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 (56,447 here).

Screw, Fixation, Bone 56,966 Implantable Pacemaker Pulse-Generator 57,343 Endoscopic Video Imaging System/Component 53,347 Suture 52,543

Similar death-typed counts

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

Computer, Diagnostic, Programmable 53 Occluder, Patent Ductus, Arteriosus 54 System, Thermal Regulating 52 Wheelchair, Mechanical 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.