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2026 data FDA MAUDE openFDA

Ureteroscope 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.

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FDA MAUDE casebook

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

#318 of 1000 · 4,829 reports · 1994–2026

  • BOOK 4,829 reports
  • RANK #318 of 1000
  • DEATH 7 death-typed
  • INJ 678 injury-typed
  • MALF 4,111 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 1,319
  • PHOTO Stimulator, Nerve

Nearest event-volume peer: Stimulator, Nerve (2 report gap)

Ureteroscope And Accessories, Flexible/Rigid sits #318 of 1000 among tracked device types with 4,829 MAUDE reports spanning 1994–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 14.0% corpus 30.4% · below corpus mean (-16.4 pp)
  • MALF 85.1% corpus 64.5% · above corpus mean (+20.6 pp)

Lead product-problem code Break is 23% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 51% of manufacturer-tagged reports · Top event location is 73% of location-tagged rows .

Ureteroscope 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 Ureteroscope And Accessories, Flexible/Rigid carries 4,829 MAUDE reports, ranked #318 of 1000.

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

Event Types

Malfunction 4,111 (85.1%)
Injury 678 (14.0%)
Other 26 (0.5%)
7 (0.1%)
Death 7 (0.1%)

Patient Outcomes

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

4,085 (82.8%)
Other 415 (8.4%)
Required Intervention 186 (3.8%)
Hospitalization 87 (1.8%)
R 57 (1.2%)
H 37 (0.8%)
O 36 (0.7%)
Life Threatening 14 (0.3%)
Death 4 (0.1%)
D 3 (0.1%)
S 3 (0.1%)
Disability 3 (0.1%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 949
Detachment of Device or Device Component 405
Failure to Clean Adequately 365
Microbial Contamination of Device 311
Adverse Event Without Identified Device or Use Problem 255
Device Reprocessing Problem 233
Loss of or Failure to Bond 195
No Display/Image 178
Peeled/Delaminated 151
Mechanical Problem 148
Material Split, Cut or Torn 129
Poor Quality Image 123
Corroded 115
Material Deformation 115
Material Protrusion/Extrusion 104
Physical Resistance/Sticking 94
Degraded 85
Mechanical Jam 81
Material Separation 75
Contamination 66

Yearly Trend

94
1994: 3
95
1995: 1
96
1996: 3
97
1997: 3
98
1998: 15
99
1999: 10
00
2000: 5
01
2001: 10
02
2002: 7
03
2003: 19
04
2004: 5
05
2005: 3
06
2006: 6
07
2007: 6
08
2008: 7
09
2009: 4
10
2010: 20
11
2011: 17
12
2012: 11
13
2013: 8
14
2014: 12
15
2015: 16
16
2016: 35
17
2017: 142
18
2018: 118
19
2019: 207
20
2020: 402
21
2021: 325
22
2022: 455
23
2023: 458
24
2024: 572
25
2025: 1,319
26
2026: 605

Related Entities for Ureteroscope And Accessories, Flexible/Rigid

Top Manufacturers

AIZU OLYMPUS CO., LTD. 2,217
OLYMPUS MEDICAL SYSTEMS CORP. 1,227
OLYMPUS WINTER & IBE GMBH 287
BOSTON SCIENTIFIC CORPORATION 214
SHIRAKAWA OLYMPUS CO., LTD. 188
KARL STORZ SE & CO. KG 161
GYRUS ACMI, INC. 46

Event Locations

3,515 (72.8%)
I 1,050 (21.7%)
HOSPITAL 206 (4.3%)
AMBULATORY SURGICAL FACILITY 31 (0.6%)
NO INFORMATION 20 (0.4%)
OTHER 4 (0.1%)
INVALID DATA 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare AIZU OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Ureteroscope 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 (4,829 here).

Stimulator, Nerve 4,827 Ophthalmic Femtosecond Laser 4,856 Accessories, Cleaning, For Endoscope 4,857 Accessories, Arthroscopic 4,870

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Warming. Blood And Plasma 7 Dressing, Wound, Occlusive 7 Image-Intensified Fluoroscopic X-Ray System 7 Instrument 7

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

Disclaimer: MAUDE figures for Ureteroscope 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 Ureteroscope 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.