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2026 data FDA MAUDE openFDA FDA Class II

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.

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 Endoscopic Video Imaging System/Component MID-BOOK · MAUDE

#60 of 1000 · 61,453 reports · 1992–2026

  • BOOK 61,453 reports
  • RANK #60 of 1000
  • DEATH 1 death-typed
  • INJ 359 injury-typed
  • MALF 61,083 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 14,682
  • PHOTO Screw, Fixation, Bone

Nearest event-volume peer: Screw, Fixation, Bone (2,827 report gap)

Endoscopic Video Imaging System/Component, Gastroenterology-Urology sits #60 of 1000 among tracked device types with 61,453 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

Endoscopic Video Imaging System/Component carries 99.4% MALFUNCTION-coded reports, 34.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.6% corpus 30.3% · below corpus mean (-29.7 pp)
  • MALF 99.4% corpus 64.8% · above corpus mean (+34.6 pp)

Lead product-problem code No Display/Image is 38% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 80% of manufacturer-tagged reports · Top event location is 88% 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 61,453 MAUDE reports, ranked #60 of 1000.

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

Event Types

Malfunction 61,083 (99.4%)
Injury 359 (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.

60,361 (99.4%)
Other 225 (0.4%)
Required Intervention 73 (0.1%)
Hospitalization 33 (0.1%)
R 21 (0.0%)
H 13 (0.0%)
O 13 (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 24,400
Poor Quality Image 9,680
Communication or Transmission Problem 8,418
Erratic or Intermittent Display 3,226
Break 2,091
Leak/Splash 1,901
Output Problem 1,808
Failure to Power Up 1,655
Connection Problem 1,525
Display or Visual Feedback Problem 1,330
Material Split, Cut or Torn 1,289
Electrical /Electronic Property Problem 1,213
Loose or Intermittent Connection 1,191
Gas/Air Leak 1,023
Corroded 924
Image Display Error/Artifact 748
Detachment of Device or Device Component 688
Power Problem 560
No Device Output 538
Crack 512

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: 14,682
26
2026: 10,604

Reports in 2025 (14,682) held close to the prior two-year average of 10,676.

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

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 48,868
OLYMPUS MEDICAL SYSTEMS CORP. 11,518
KARL STORZ SE & CO. KG 408
SHIRAKAWA OLYMPUS CO., LTD 133
BOSTON SCIENTIFIC CORPORATION 37
HOYA CORPORATION PENTAX TOKYO OFFICE 31
AIZU OLYMPUS CO., LTD. 28

Event Locations

54,264 (88.3%)
I 7,046 (11.5%)
HOSPITAL 127 (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%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Endoscopic Video Imaging System/Component: 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 (61,453 here).

Screw, Fixation, Bone 58,626 Implantable Pacemaker Pulse-Generator 57,769 Suture 56,265 Pacemaker/Icd/Crt Non-Implanted Components 55,908

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.