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2026 data FDA MAUDE openFDA FDA Class II

Choledochoscope 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 Choledochoscope And Accessories LIGHT-BOOK · MAUDE

#466 of 1000 · 2,300 reports · 1995–2026

  • BOOK 2,300 reports
  • RANK #466 of 1000
  • DEATH 9 death-typed
  • INJ 130 injury-typed
  • MALF 2,159 malfunction
  • SPAN 1995–2026
  • PEAK 2018: 639
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Hemi-, Femoral (14 report gap)

Choledochoscope And Accessories, Flexible/Rigid sits #466 of 1000 among tracked device types with 2,300 MAUDE reports spanning 1995–2026. 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

Choledochoscope And Accessories carries 93.9% MALFUNCTION-coded reports, 29.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 5.7% corpus 30.3% · below corpus mean (-24.6 pp)
  • MALF 93.9% corpus 64.8% · above corpus mean (+29.0 pp)

Lead product-problem code Material Protrusion/Extrusion is 36% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 55% of manufacturer-tagged reports · Top event location I is 61% of location-tagged rows .

Choledochoscope And Accessories in the event-volume neighbourhood

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

reports

What this shows Choledochoscope And Accessories, Flexible/Rigid carries 2,300 MAUDE reports, ranked #466 of 1000.

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

Event Types

Malfunction 2,159 (93.9%)
Injury 130 (5.7%)
Death 9 (0.4%)
Other 2 (0.1%)

Patient Outcomes

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

2,144 (92.3%)
Other 61 (2.6%)
Required Intervention 59 (2.5%)
R 17 (0.7%)
Hospitalization 17 (0.7%)
O 8 (0.3%)
Death 7 (0.3%)
H 5 (0.2%)
Life Threatening 3 (0.1%)
D 2 (0.1%)
L 1 (0.0%)

Top Product Problems

Material Protrusion/Extrusion 1,063
Optical Problem 765
Appropriate Device Problem Term/Code Not Available 320
Poor Quality Image 206
Adverse Event Without Identified Device or Use Problem 147
Device-Device Incompatibility 127
Difficult to Advance 52
Detachment of Device or Device Component 30
Peeled/Delaminated 27
Break 26
Corroded 21
Insufficient Device Problem Information 19
Detachment Of Device Component 18
Defective Device 15
Device Reprocessing Problem 14
Material Integrity Problem 14
No Display/Image 14
Physical Resistance/Sticking 14
Connection Problem 13
Failure to Clean Adequately 13

Yearly Trend

95
1995: 2
96
1996: 2
97
1997: 2
04
2004: 1
06
2006: 1
07
2007: 1
08
2008: 5
09
2009: 4
10
2010: 2
11
2011: 2
13
2013: 2
14
2014: 2
15
2015: 2
16
2016: 168
17
2017: 224
18
2018: 639
19
2019: 105
20
2020: 173
21
2021: 158
22
2022: 283
23
2023: 105
24
2024: 107
25
2025: 119
26
2026: 191

Reports in 2025 (119) held close to the prior two-year average of 106.

Related Entities for Choledochoscope And Accessories, Flexible/Rigid

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 1,253
BOSTON SCIENTIFIC - SPENCER 692
AIZU OLYMPUS CO., LTD. 168
BOSTON SCIENTIFIC - MARLBOROUGH 80
OLYMPUS MEDICAL SYSTEMS CORP. 69
HOYA CORPORATION PENTAX TOKYO OFFICE 3

Event Locations

I 1,413 (61.4%)
846 (36.8%)
HOSPITAL 32 (1.4%)
NO INFORMATION 7 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs BOSTON SCIENTIFIC - SPENCER →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Choledochoscope And Accessories: 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 (2,300 here).

Prosthesis, Knee, Hemi-, Femoral 2,314 Pulmonary Valve Prosthesis Percutaneously D… 2,280 Prosthesis 2,276 Catheter, Intravascular Occluding, Temporary 2,330

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Connector, Airway 9 Cuff, Tracheal Tube, Inflatable 9

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

Disclaimer: MAUDE figures for Choledochoscope And Accessories 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 Choledochoscope And Accessories; 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.