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2026 data FDA MAUDE openFDA FDA Class I

Microscope, Surgical

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4700 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Microscope, Surgical LIGHT-BOOK · MAUDE

#913 of 1000 · 473 reports · 1992–2026

  • BOOK 473 reports
  • RANK #913 of 1000
  • DEATH 0 death-typed
  • INJ 123 injury-typed
  • MALF 321 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 44
  • PHOTO Heart-Valve, Allograft

Nearest event-volume peer: Heart-Valve, Allograft (1 report gap)

Microscope, Surgical sits #913 of 1000 among tracked device types with 473 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Microscope, Surgical carries 26.0% INJURY-coded reports, 4.3pp below 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 26.0% corpus 30.3% · below corpus mean (-4.3 pp)
  • MALF 67.9% corpus 64.8% · above corpus mean (+3.0 pp)

Lead product-problem code Electrical /Electronic Property Problem is 27% of coded problems · Top event location is 68% of location-tagged rows .

Microscope, Surgical in the event-volume neighbourhood

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

reports

What this shows Microscope, Surgical carries 473 MAUDE reports, ranked #913 of 1000.

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

Event Types

Malfunction 321 (67.9%)
Injury 123 (26.0%)
Other 23 (4.9%)
6 (1.3%)

Patient Outcomes

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

291 (59.3%)
Other 120 (24.4%)
Required Intervention 43 (8.8%)
Disability 10 (2.0%)
Hospitalization 8 (1.6%)
R 6 (1.2%)
S 5 (1.0%)
O 4 (0.8%)
H 1 (0.2%)
L 1 (0.2%)
Death 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Electrical /Electronic Property Problem 112
Insufficient Device Problem Information 35
Device Operates Differently Than Expected 28
Component Falling 27
Unknown (for use when the device problem is not known) 26
Use of Device Problem 24
Adverse Event Without Identified Device or Use Problem 23
Detachment Of Device Component 18
Overheating of Device 16
Material Split, Cut or Torn 14
Break 13
Device Tipped Over 13
Detachment of Device or Device Component 10
Improper or Incorrect Procedure or Method 10
Loss of Power 10
Device Operational Issue 9
Loose 8
Other (for use when an appropriate device code cannot be identified) 8
Repair 8
Burst Container or Vessel 7

Yearly Trend

92
1992: 2
93
1993: 1
95
1995: 2
96
1996: 4
97
1997: 2
98
1998: 1
99
1999: 3
00
2000: 1
01
2001: 2
02
2002: 3
03
2003: 8
04
2004: 5
05
2005: 15
06
2006: 24
07
2007: 17
08
2008: 8
09
2009: 9
10
2010: 6
11
2011: 37
12
2012: 36
13
2013: 27
14
2014: 25
15
2015: 14
16
2016: 13
17
2017: 13
18
2018: 13
19
2019: 15
20
2020: 10
21
2021: 31
22
2022: 42
23
2023: 44
24
2024: 16
25
2025: 14
26
2026: 10

Reports fell to 14 in 2025, down from an average of 30 in the two years before.

Related Entities for Microscope, Surgical

Event Locations

321 (67.9%)
I 79 (16.7%)
HOSPITAL 63 (13.3%)
AMBULATORY SURGICAL FACILITY 4 (0.8%)
NO INFORMATION 4 (0.8%)
INVALID DATA 1 (0.2%)
UNKNOWN 1 (0.2%)

Nationwide devices with a comparable report-volume footprint

Microscope, Surgical carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (473 here).

Heart-Valve, Allograft 474 System, Identification, Hepatitis B Antigen 472 Implantable Transprostatic Tissue Retractor… 471 Nucleic-Acid Tests Used For Infectious Dise… 475

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Microscope, Surgical 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 Microscope, Surgical; 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.