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Dislodger, Stone, Basket, Ureteral, Metal

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Dislodger, Stone, Basket, Ureteral, Metal

The FDA MAUDE database aggregates 5,930 adverse-event reports for Dislodger, Stone, Basket, Ureteral, Metal spanning the period from 1992 through 2026. Of these, 5 are classified as death reports, 993 as injury reports, and 4,885 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 12 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Difficult to Open or Close topping the list at 1,779 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 607 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 10 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

5,930
Total Reports
5
Death Reports
993
Injury Reports
4,885
Malfunctions

Event Types

Malfunction 4,885 (82.4%)
Injury 993 (16.7%)
Other 25 (0.4%)
22 (0.4%)
Death 5 (0.1%)

Patient Outcomes

4,759 (78.2%)
Required Intervention 796 (13.1%)
Other 231 (3.8%)
Hospitalization 125 (2.1%)
R 117 (1.9%)
H 23 (0.4%)
O 13 (0.2%)
Disability 8 (0.1%)
Death 5 (0.1%)
S 4 (0.1%)
Congenital Anomaly 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Difficult to Open or Close 1,779
Break 1,258
Detachment of Device or Device Component 291
Material Separation 218
Material Deformation 182
Fracture 173
Adverse Event Without Identified Device or Use Problem 161
Loss of or Failure to Bond 143
Material Split, Cut or Torn 141
Device Operates Differently Than Expected 113
Material Twisted/Bent 90
Device Damaged Prior to Use 68
Deformation Due to Compressive Stress 52
Material Fragmentation 42
Device Contaminated During Manufacture or Shipping 40
Difficult to Fold, Unfold or Collapse 39
Detachment Of Device Component 32
Difficult to Remove 29
Difficult or Delayed Positioning 23
Mechanical Problem 22

Yearly Trend

92
1992: 4
93
1993: 7
94
1994: 6
95
1995: 23
96
1996: 30
97
1997: 35
98
1998: 34
99
1999: 14
00
2000: 16
01
2001: 8
02
2002: 27
03
2003: 51
04
2004: 59
05
2005: 100
06
2006: 107
07
2007: 68
08
2008: 152
09
2009: 194
10
2010: 192
11
2011: 129
12
2012: 95
13
2013: 98
14
2014: 71
15
2015: 79
16
2016: 88
17
2017: 517
18
2018: 428
19
2019: 351
20
2020: 375
21
2021: 358
22
2022: 426
23
2023: 593
24
2024: 607
25
2025: 510
26
2026: 78

Related Entities for Dislodger, Stone, Basket, Ureteral, Metal

Event Locations

3,440 (58.0%)
I 1,912 (32.2%)
HOSPITAL 496 (8.4%)
NO INFORMATION 36 (0.6%)
INVALID DATA 16 (0.3%)
OTHER 9 (0.2%)
OUTPATIENT TREATMENT FACILITY 8 (0.1%)
AMBULATORY SURGICAL FACILITY 6 (0.1%)
NOT APPLICABLE 5 (0.1%)
UNKNOWN 2 (0.0%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.