2026 data FDA MAUDE openFDA FDA Class II

Dislodger, Stone, Biliary

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 §876.5010 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Dislodger, Stone, Biliary LIGHT-BOOK · MAUDE

#712 of 1000 · 847 reports · 1995–2026

  • BOOK 847 reports
  • RANK #712 of 1000
  • DEATH 5 death-typed
  • INJ 135 injury-typed
  • MALF 704 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 112
  • PHOTO Incubator, Neonatal

Nearest event-volume peer: Incubator, Neonatal (0 report gap)

Dislodger, Stone, Biliary sits #712 of 1000 among tracked device types with 847 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

Dislodger, Stone, Biliary carries 83.1% MALFUNCTION-coded reports, 18.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 15.9% corpus 30.3% · below corpus mean (-14.4 pp)
  • MALF 83.1% corpus 64.8% · above corpus mean (+18.3 pp)

Lead product-problem code Break is 31% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 25% of manufacturer-tagged reports · Top event location is 70% of location-tagged rows .

Dislodger, Stone, Biliary in the event-volume neighbourhood

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

reports

What this shows Dislodger, Stone, Biliary carries 847 MAUDE reports, ranked #712 of 1000.

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

Event Types

Malfunction 704 (83.1%)
Injury 135 (15.9%)
Death 5 (0.6%)
Other 2 (0.2%)
1 (0.1%)

Patient Outcomes

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

692 (78.6%)
Required Intervention 95 (10.8%)
Other 38 (4.3%)
R 18 (2.0%)
Hospitalization 16 (1.8%)
O 7 (0.8%)
H 6 (0.7%)
S 2 (0.2%)
Death 2 (0.2%)
Disability 2 (0.2%)
D 1 (0.1%)
L 1 (0.1%)

Top Product Problems

Break 284
Difficult to Fold, Unfold or Collapse 82
Material Separation 66
Adverse Event Without Identified Device or Use Problem 64
Fracture 63
Failure to Conduct 51
Difficult to Remove 48
Difficult to Open or Close 31
Detachment of Device or Device Component 29
Positioning Problem 28
Material Rupture 26
Material Deformation 22
Component(s), broken 18
Material Split, Cut or Torn 17
Wire(s), breakage of 16
Entrapment of Device 15
Deformation Due to Compressive Stress 13
Replace 11
Defective Device 9
Detachment Of Device Component 9

Yearly Trend

95
1995: 3
96
1996: 2
97
1997: 3
98
1998: 2
00
2000: 2
01
2001: 1
02
2002: 4
03
2003: 4
04
2004: 7
05
2005: 4
06
2006: 8
07
2007: 23
08
2008: 4
09
2009: 25
10
2010: 39
11
2011: 47
12
2012: 50
13
2013: 13
14
2014: 21
15
2015: 12
16
2016: 4
17
2017: 11
18
2018: 43
19
2019: 41
20
2020: 51
21
2021: 47
22
2022: 58
23
2023: 71
24
2024: 69
25
2025: 112
26
2026: 66

Reports rose to 112 in 2025, up from an average of 70 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Dislodger, Stone, Biliary

Event Locations

595 (70.2%)
I 184 (21.7%)
HOSPITAL 60 (7.1%)
NO INFORMATION 5 (0.6%)
AMBULATORY SURGICAL FACILITY 2 (0.2%)
OTHER 1 (0.1%)

Compare BOSTON SCIENTIFIC CORPORATION vs WILSON-COOK MEDICAL INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dislodger, Stone, Biliary: 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 (847 here).

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Disclaimer: MAUDE figures for Dislodger, Stone, Biliary 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 Dislodger, Stone, Biliary; 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.