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2026 data FDA MAUDE openFDA FDA Class II

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.

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

#277 of 1000 · 6,637 reports · 1994–2026

  • BOOK 6,637 reports
  • RANK #277 of 1000
  • DEATH 7 death-typed
  • INJ 705 injury-typed
  • MALF 5,890 malfunction
  • SPAN 1994–2026
  • PEAK 2026: 2,412
  • PHOTO Hearing Aid

Nearest event-volume peer: Hearing Aid, Bone Conduction, Implanted (41 report gap)

Ureteroscope And Accessories, Flexible/Rigid sits #277 of 1000 among tracked device types with 6,637 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 →

Malfunction reports run above the device-type norm

Ureteroscope And Accessories, Flexible/Rigid carries 88.7% MALFUNCTION-coded reports, 23.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 10.6% corpus 30.3% · below corpus mean (-19.7 pp)
  • MALF 88.7% corpus 64.8% · above corpus mean (+23.9 pp)

Lead product-problem code Break is 19% of coded problems · Lead manufacturer AIZU OLYMPUS CO., LTD. accounts for 61% of manufacturer-tagged reports · Top event location is 80% 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 6,637 MAUDE reports, ranked #277 of 1000.

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

Event Types

Malfunction 5,890 (88.7%)
Injury 705 (10.6%)
Other 28 (0.4%)
7 (0.1%)
Death 7 (0.1%)

Patient Outcomes

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

5,781 (86.6%)
Other 434 (6.5%)
Required Intervention 198 (3.0%)
Hospitalization 91 (1.4%)
R 61 (0.9%)
H 40 (0.6%)
O 39 (0.6%)
Life Threatening 15 (0.2%)
Death 4 (0.1%)
D 3 (0.0%)
S 3 (0.0%)
Disability 3 (0.0%)
L 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 1,107
Detachment of Device or Device Component 880
Loss of or Failure to Bond 499
Failure to Clean Adequately 474
Microbial Contamination of Device 318
Device Reprocessing Problem 281
Corroded 273
Adverse Event Without Identified Device or Use Problem 271
No Display/Image 226
Peeled/Delaminated 219
Material Split, Cut or Torn 169
Physical Resistance/Sticking 161
Mechanical Problem 157
Material Deformation 155
Poor Quality Image 149
Degraded 138
Material Protrusion/Extrusion 124
Crack 116
Material Fragmentation 111
Mechanical Jam 106

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: 1,320
26
2026: 2,412

Reports rose to 1,320 in 2025, up from an average of 515 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Ureteroscope And Accessories, Flexible/Rigid

Top Manufacturers

AIZU OLYMPUS CO., LTD. 3,651
OLYMPUS MEDICAL SYSTEMS CORP. 1,228
SHIRAKAWA OLYMPUS CO., LTD. 326
OLYMPUS WINTER & IBE GMBH 298
BOSTON SCIENTIFIC CORPORATION 232
KARL STORZ SE & CO. KG 202
GYRUS ACMI, INC. 54

Event Locations

5,310 (80.0%)
I 1,050 (15.8%)
HOSPITAL 218 (3.3%)
AMBULATORY SURGICAL FACILITY 31 (0.5%)
NO INFORMATION 20 (0.3%)
OTHER 4 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
INVALID DATA 1 (0.0%)
UNKNOWN 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Ureteroscope 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 (6,637 here).

Hearing Aid, Bone Conduction, Implanted 6,678 Tube, Tracheostomy 6,588 Prosthesis 6,699 Separator, Automated, Blood Cell, Diagnostic 6,575

Similar death-typed counts

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

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 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.