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2026 data FDA MAUDE openFDA FDA Class II

Cystoscope And Accessories, Flexible/Rigid

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 Cystoscope And Accessories, Flexible/Rigid MID-BOOK · MAUDE

#209 of 1000 · 10,640 reports · 1993–2026

  • BOOK 10,640 reports
  • RANK #209 of 1000
  • DEATH 3 death-typed
  • INJ 782 injury-typed
  • MALF 9,809 malfunction
  • SPAN 1993–2026
  • PEAK 2026: 4,042
  • PHOTO Oxygenator

Nearest event-volume peer: Oxygenator, Cardiopulmonary Bypass (28 report gap)

Cystoscope And Accessories, Flexible/Rigid sits #209 of 1000 among tracked device types with 10,640 MAUDE reports spanning 1993–2026. 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

Cystoscope And Accessories, Flexible/Rigid carries 92.2% MALFUNCTION-coded reports, 27.4pp 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 7.3% corpus 30.3% · below corpus mean (-22.9 pp)
  • MALF 92.2% corpus 64.8% · above corpus mean (+27.4 pp)

Lead product-problem code Detachment of Device or Device Component is 29% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 77% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .

Cystoscope And Accessories, Flexible/Rigid in the event-volume neighbourhood

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

reports

What this shows Cystoscope And Accessories, Flexible/Rigid carries 10,640 MAUDE reports, ranked #209 of 1000.

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

Event Types

Malfunction 9,809 (92.2%)
Injury 782 (7.3%)
Other 37 (0.3%)
9 (0.1%)
Death 3 (0.0%)

Patient Outcomes

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

9,600 (90.9%)
Other 509 (4.8%)
Required Intervention 235 (2.2%)
Hospitalization 93 (0.9%)
R 48 (0.5%)
O 45 (0.4%)
H 11 (0.1%)
L 7 (0.1%)
Life Threatening 6 (0.1%)
S 4 (0.0%)
Disability 3 (0.0%)
Death 2 (0.0%)
D 1 (0.0%)

Top Product Problems

Detachment of Device or Device Component 2,980
Failure to Clean Adequately 960
Device Reprocessing Problem 776
Corroded 730
Loss of or Failure to Bond 707
Break 695
Microbial Contamination of Device 565
No Display/Image 410
Material Separation 317
Peeled/Delaminated 286
Material Split, Cut or Torn 236
Material Deformation 226
Degraded 225
Poor Quality Image 220
Fluid/Blood Leak 209
Adverse Event Without Identified Device or Use Problem 198
Crack 154
Contamination 152
Erratic or Intermittent Display 135
Loose or Intermittent Connection 129

Yearly Trend

93
1993: 1
94
1994: 1
95
1995: 5
96
1996: 4
97
1997: 5
98
1998: 3
99
1999: 4
00
2000: 5
01
2001: 8
02
2002: 9
03
2003: 4
04
2004: 4
05
2005: 9
06
2006: 6
07
2007: 9
08
2008: 10
09
2009: 10
10
2010: 9
11
2011: 13
12
2012: 8
13
2013: 12
14
2014: 6
15
2015: 28
16
2016: 75
17
2017: 79
18
2018: 79
19
2019: 102
20
2020: 339
21
2021: 494
22
2022: 744
23
2023: 920
24
2024: 892
25
2025: 2,701
26
2026: 4,042

Reports rose to 2,701 in 2025, up from an average of 906 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Cystoscope And Accessories, Flexible/Rigid

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 7,752
OLYMPUS MEDICAL SYSTEMS CORP. 1,228
HOYA CORPORATION PENTAX TOKYO OFFICE 498
AIZU OLYMPUS CO., LTD. 263
KARL STORZ SE & CO. KG 164
OLYMPUS WINTER & IBE GMBH 138

Event Locations

9,466 (89.0%)
I 901 (8.5%)
HOSPITAL 177 (1.7%)
AMBULATORY SURGICAL FACILITY 44 (0.4%)
NO INFORMATION 18 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 18 (0.2%)
OTHER 12 (0.1%)
INVALID DATA 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (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 Cystoscope And Accessories, Flexible/Rigid: 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 (10,640 here).

Oxygenator, Cardiopulmonary Bypass 10,612 Walker, Mechanical 10,673 Ligator, Esophageal 10,683 Stent, Superficial Femoral Artery 10,573

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Cystoscope And Accessories, Flexible/Rigid 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 Cystoscope And Accessories, Flexible/Rigid; 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.