PlainHospital
2026 data FDA MAUDE openFDA

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Cystoscope And Accessories, Flexible/Rigid LIGHT-BOOK · MAUDE

#248 of 1000 · 7,356 reports · 1993–2026

  • BOOK 7,356 reports
  • RANK #248 of 1000
  • DEATH 3 death-typed
  • INJ 779 injury-typed
  • MALF 6,528 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 2,703
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Ultrasound, Intravascular (28 report gap)

Cystoscope And Accessories, Flexible/Rigid sits #248 of 1000 among tracked device types with 7,356 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 →

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 10.6% corpus 30.4% · below corpus mean (-19.8 pp)
  • MALF 88.7% corpus 64.5% · above corpus mean (+24.2 pp)

Lead product-problem code Detachment of Device or Device Component is 24% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 68% of manufacturer-tagged reports · Top event location is 84% 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 7,356 MAUDE reports, ranked #248 of 1000.

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

Event Types

Malfunction 6,528 (88.7%)
Injury 779 (10.6%)
Other 37 (0.5%)
9 (0.1%)
Death 3 (0.0%)

Patient Outcomes

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

6,498 (87.3%)
Other 502 (6.7%)
Required Intervention 229 (3.1%)
Hospitalization 90 (1.2%)
R 48 (0.6%)
O 45 (0.6%)
H 11 (0.1%)
L 7 (0.1%)
Life Threatening 6 (0.1%)
S 4 (0.1%)
Disability 3 (0.0%)
Death 2 (0.0%)
D 1 (0.0%)

Top Product Problems

Detachment of Device or Device Component 1,633
Failure to Clean Adequately 705
Device Reprocessing Problem 591
Microbial Contamination of Device 539
Break 533
No Display/Image 399
Corroded 296
Fluid/Blood Leak 203
Material Separation 188
Peeled/Delaminated 187
Material Split, Cut or Torn 183
Poor Quality Image 183
Adverse Event Without Identified Device or Use Problem 177
Loss of or Failure to Bond 152
Material Deformation 139
Erratic or Intermittent Display 135
Contamination 127
Loose or Intermittent Connection 116
Degraded 112
Contamination /Decontamination Problem 95

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: 2,703
26
2026: 756

Related Entities for Cystoscope And Accessories, Flexible/Rigid

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 4,648
OLYMPUS MEDICAL SYSTEMS CORP. 1,228
HOYA CORPORATION PENTAX TOKYO OFFICE 491
AIZU OLYMPUS CO., LTD. 212
KARL STORZ SE & CO. KG 129
OLYMPUS WINTER & IBE GMBH 93
SHIRAKAWA OLYMPUS CO., LTD 36

Event Locations

6,189 (84.1%)
I 901 (12.2%)
HOSPITAL 173 (2.4%)
AMBULATORY SURGICAL FACILITY 43 (0.6%)
NO INFORMATION 18 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 18 (0.2%)
OTHER 10 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Cystoscope And Accessories, Flexible/Rigid, 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 (7,356 here).

Catheter, Ultrasound, Intravascular 7,328 Catheter 7,318 Abutment, Implant, Dental, Endosseous 7,311 Intracranial Neurovascular Stent 7,431

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.