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2026 data FDA MAUDE openFDA

Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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.

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FDA MAUDE casebook

openFDA event book Endoscopic Video Imaging System/Component MID-BOOK · MAUDE

#62 of 1000 · 53,347 reports · 1992–2026

  • BOOK 53,347 reports
  • RANK #62 of 1000
  • DEATH 1 death-typed
  • INJ 336 injury-typed
  • MALF 53,000 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 14,681
  • PHOTO Suture

Nearest event-volume peer: Suture, Absorbable, Synthetic, Polyglycolic Acid (804 report gap)

Endoscopic Video Imaging System/Component, Gastroenterology-Urology sits #62 of 1000 among tracked device types with 53,347 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.6% corpus 30.4% · below corpus mean (-29.8 pp)
  • MALF 99.3% corpus 64.5% · above corpus mean (+34.8 pp)

Lead product-problem code No Display/Image is 40% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 77% of manufacturer-tagged reports · Top event location is 87% of location-tagged rows .

Endoscopic Video Imaging System/Component in the event-volume neighbourhood

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

reports

What this shows Endoscopic Video Imaging System/Component, Gastroenterology-Urology carries 53,347 MAUDE reports, ranked #62 of 1000.

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

Event Types

Malfunction 53,000 (99.3%)
Injury 336 (0.6%)
5 (0.0%)
Other 5 (0.0%)
Death 1 (0.0%)

Patient Outcomes

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

52,821 (99.3%)
Other 203 (0.4%)
Required Intervention 70 (0.1%)
Hospitalization 31 (0.1%)
R 20 (0.0%)
H 13 (0.0%)
O 11 (0.0%)
L 3 (0.0%)
Life Threatening 3 (0.0%)
Death 2 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

No Display/Image 22,175
Poor Quality Image 7,919
Communication or Transmission Problem 7,095
Erratic or Intermittent Display 2,646
Break 1,870
Failure to Power Up 1,520
Output Problem 1,497
Leak/Splash 1,460
Connection Problem 1,266
Electrical /Electronic Property Problem 1,190
Display or Visual Feedback Problem 1,179
Material Split, Cut or Torn 1,150
Loose or Intermittent Connection 943
Corroded 684
Image Display Error/Artifact 650
Gas/Air Leak 644
Detachment of Device or Device Component 541
Power Problem 521
Crack 464
No Device Output 452

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 1
95
1995: 2
96
1996: 8
97
1997: 6
98
1998: 8
99
1999: 1
00
2000: 2
01
2001: 3
05
2005: 1
06
2006: 4
07
2007: 2
08
2008: 1
09
2009: 6
10
2010: 3
11
2011: 7
12
2012: 11
13
2013: 8
14
2014: 3
15
2015: 3
16
2016: 25
17
2017: 67
18
2018: 68
19
2019: 72
20
2020: 3,043
21
2021: 5,302
22
2022: 6,156
23
2023: 8,199
24
2024: 13,153
25
2025: 14,681
26
2026: 2,499

Related Entities for Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 40,974
OLYMPUS MEDICAL SYSTEMS CORP. 11,518
KARL STORZ SE & CO. KG 287
SHIRAKAWA OLYMPUS CO., LTD 133
HOYA CORPORATION PENTAX TOKYO OFFICE 31
AIZU OLYMPUS CO., LTD. 28
BOSTON SCIENTIFIC CORPORATION 28

Event Locations

46,167 (86.5%)
I 7,046 (13.2%)
HOSPITAL 119 (0.2%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
NO INFORMATION 4 (0.0%)
OTHER 4 (0.0%)
LABORATORY 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
UNKNOWN 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Endoscopic Video Imaging System/Component, 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 (53,347 here).

Suture 52,543 Generator, Oxygen, Portable 52,481 Stimulator 51,502 Stimulator 51,263

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Endoscopic Video Imaging System/Component 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 Endoscopic Video Imaging System/Component; 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.