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2026 data FDA MAUDE openFDA

Light Source, Fiberoptic, Routine

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 Light Source, Fiberoptic, Routine LIGHT-BOOK · MAUDE

#407 of 1000 · 2,885 reports · 1995–2026

  • BOOK 2,885 reports
  • RANK #407 of 1000
  • DEATH 1 death-typed
  • INJ 146 injury-typed
  • MALF 2,717 malfunction
  • SPAN 1995–2026
  • PEAK 2010: 713
  • PHOTO Endoscopic Tissue App…

Nearest event-volume peer: Endoscopic Tissue Approximation Device (7 report gap)

Light Source, Fiberoptic, Routine sits #407 of 1000 among tracked device types with 2,885 MAUDE reports spanning 1995–2026. 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 5.1% corpus 30.4% · below corpus mean (-25.4 pp)
  • MALF 94.2% corpus 64.5% · above corpus mean (+29.7 pp)

Lead product-problem code Output Problem is 15% of coded problems · Lead manufacturer STRYKER ENDOSCOPY SAN JOSE accounts for 74% of manufacturer-tagged reports · Top event location is 78% of location-tagged rows .

Light Source, Fiberoptic, Routine in the event-volume neighbourhood

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

reports

What this shows Light Source, Fiberoptic, Routine carries 2,885 MAUDE reports, ranked #407 of 1000.

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

Event Types

Malfunction 2,717 (94.2%)
Injury 146 (5.1%)
12 (0.4%)
Other 9 (0.3%)
Death 1 (0.0%)

Patient Outcomes

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

2,728 (94.4%)
Other 136 (4.7%)
Required Intervention 16 (0.6%)
R 3 (0.1%)
O 2 (0.1%)
H 1 (0.0%)
L 1 (0.0%)
S 1 (0.0%)
Death 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Output Problem 206
Overheating of Device 205
Smoking 126
Display or Visual Feedback Problem 110
Temperature Problem 108
Circuit Failure 87
Device Emits Odor 74
Electrical /Electronic Property Problem 56
Thermal Decomposition of Device 47
Break 43
Melted 43
Failure to Power Up 41
No Display/Image 41
Adverse Event Without Identified Device or Use Problem 40
Detachment of Device or Device Component 34
Use of Device Problem 34
Power Problem 33
Poor Quality Image 29
Connection Problem 26
Loss of Power 23

Yearly Trend

95
1995: 1
96
1996: 1
98
1998: 1
00
2000: 1
01
2001: 1
02
2002: 2
06
2006: 2
07
2007: 3
08
2008: 2
09
2009: 148
10
2010: 713
11
2011: 603
12
2012: 77
13
2013: 29
14
2014: 11
15
2015: 24
16
2016: 29
17
2017: 59
18
2018: 76
19
2019: 118
20
2020: 152
21
2021: 147
22
2022: 166
23
2023: 179
24
2024: 179
25
2025: 141
26
2026: 20

Related Entities for Light Source, Fiberoptic, Routine

Top Manufacturers

STRYKER ENDOSCOPY SAN JOSE 1,469
STRYKER ENDOSCOPY-SAN JOSE 307
MEDOS INTERNATIONAL SARL 91
KARL STORZ SE & CO. KG 77
DEPUY MITEK LLC US 28

Event Locations

2,263 (78.4%)
I 534 (18.5%)
HOSPITAL 74 (2.6%)
NO INFORMATION 12 (0.4%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)

Compare STRYKER ENDOSCOPY SAN JOSE vs STRYKER ENDOSCOPY-SAN JOSE →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Light Source, Fiberoptic, Routine, 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 (2,885 here).

Endoscopic Tissue Approximation Device 2,878 Prosthesis, Spinous Process Spacer/Plate 2,895 Syringe, Antistick 2,905 Adaptor, Hygiene 2,907

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 Light Source, Fiberoptic, Routine 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, Fiberoptic, Routine; 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.