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2026 data FDA MAUDE openFDA FDA Class II

Light Source, Endoscope, Xenon Arc

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 Light Source, Endoscope, Xenon Arc LIGHT-BOOK · MAUDE

#463 of 1000 · 2,332 reports · 1996–2026

  • BOOK 2,332 reports
  • RANK #463 of 1000
  • DEATH 5 death-typed
  • INJ 87 injury-typed
  • MALF 2,192 malfunction
  • SPAN 1996–2026
  • PEAK 2026: 380
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Intravascular Occluding, Temporary (2 report gap)

Light Source, Endoscope, Xenon Arc sits #463 of 1000 among tracked device types with 2,332 MAUDE reports spanning 1996–2026. 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

Light Source, Endoscope, Xenon Arc carries 94.0% MALFUNCTION-coded reports, 29.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 3.7% corpus 30.3% · below corpus mean (-26.6 pp)
  • MALF 94.0% corpus 64.8% · above corpus mean (+29.2 pp)

Lead product-problem code No Display/Image is 23% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 63% of manufacturer-tagged reports · Top event location is 85% of location-tagged rows .

Light Source, Endoscope, Xenon Arc in the event-volume neighbourhood

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

reports

What this shows Light Source, Endoscope, Xenon Arc carries 2,332 MAUDE reports, ranked #463 of 1000.

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

Event Types

Malfunction 2,192 (94.0%)
Injury 87 (3.7%)
Other 33 (1.4%)
15 (0.6%)
Death 5 (0.2%)

Patient Outcomes

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

2,172 (94.6%)
Other 63 (2.7%)
Required Intervention 34 (1.5%)
Hospitalization 13 (0.6%)
Death 4 (0.2%)
O 3 (0.1%)
R 3 (0.1%)
S 2 (0.1%)
H 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

No Display/Image 447
Poor Quality Image 219
Electrical /Electronic Property Problem 190
Device Displays Incorrect Message 141
Erratic or Intermittent Display 124
Failure to Power Up 111
No Device Output 111
Output Problem 71
Activation Failure 70
Break 62
Display or Visual Feedback Problem 53
Communication or Transmission Problem 48
No Visual Prompts/Feedback 46
Loss of Power 44
Optical Problem 43
Device Operates Differently Than Expected 42
Unknown (for use when the device problem is not known) 35
Defective Device 34
Thermal Decomposition of Device 34
Overheating of Device 33

Yearly Trend

96
1996: 2
97
1997: 3
98
1998: 2
99
1999: 3
00
2000: 2
01
2001: 4
02
2002: 4
03
2003: 14
04
2004: 10
05
2005: 116
06
2006: 30
07
2007: 32
08
2008: 29
09
2009: 153
10
2010: 21
11
2011: 132
12
2012: 36
13
2013: 7
14
2014: 11
15
2015: 8
16
2016: 15
17
2017: 14
18
2018: 20
19
2019: 18
20
2020: 114
21
2021: 149
22
2022: 158
23
2023: 200
24
2024: 296
25
2025: 349
26
2026: 380

Reports rose to 349 in 2025, up from an average of 248 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Light Source, Endoscope, Xenon Arc

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 1,266
OLYMPUS MEDICAL SYSTEMS CORP. 417
STRYKER ENDOSCOPY SAN JOSE 309
KARL STORZ SE & CO. KG 9
STRYKER ENDOSCOPY - SAN JOSE 7

Event Locations

1,974 (84.6%)
I 299 (12.8%)
HOSPITAL 50 (2.1%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
INVALID DATA 3 (0.1%)
NO INFORMATION 2 (0.1%)
OTHER 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 Light Source, Endoscope, Xenon Arc: 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 (2,332 here).

Catheter, Intravascular Occluding, Temporary 2,330 Circuit, Breathing 2,347 Prosthesis, Knee, Hemi-, Femoral 2,314 Catheter, Peritoneal, Long-Term Indwelling 2,355

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

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

Disclaimer: MAUDE figures for Light Source, Endoscope, Xenon Arc 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 Light Source, Endoscope, Xenon Arc; 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.