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TPLC
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Device
dislodger, stone, basket, ureteral, metal
Regulation Description
Ureteral stone dislodger.
Product Code
FFL
Regulation Number
876.4680
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
375
375
2021
358
358
2022
426
426
2023
593
593
2024
606
606
2025
192
192
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Open or Close
1187
1187
Break
627
627
Detachment of Device or Device Component
199
199
Material Separation
132
132
Material Deformation
131
131
Adverse Event Without Identified Device or Use Problem
130
130
Material Split, Cut or Torn
119
119
Fracture
119
119
Loss of or Failure to Bond
99
99
Material Twisted/Bent
67
67
Device Contaminated During Manufacture or Shipping
35
35
Deformation Due to Compressive Stress
34
34
Difficult to Fold, Unfold or Collapse
33
33
Material Fragmentation
31
31
Device Damaged Prior to Use
29
29
Unsealed Device Packaging
14
14
Defective Device
13
13
Nonstandard Device
12
12
Difficult to Remove
12
12
Device Contamination with Chemical or Other Material
9
9
Tear, Rip or Hole in Device Packaging
8
8
Use of Device Problem
7
7
Contamination /Decontamination Problem
6
6
Appropriate Term/Code Not Available
6
6
Insufficient Information
6
6
Disconnection
5
5
Difficult to Advance
4
4
Physical Resistance/Sticking
4
4
Packaging Problem
4
4
Material Frayed
4
4
Device Damaged by Another Device
3
3
Activation, Positioning or Separation Problem
3
3
Sharp Edges
3
3
Component Misassembled
3
3
Entrapment of Device
3
3
Loose or Intermittent Connection
3
3
Component Missing
3
3
Off-Label Use
2
2
Peeled/Delaminated
2
2
Mechanical Problem
2
2
Device Handling Problem
2
2
Difficult to Insert
2
2
Defective Component
2
2
Device-Device Incompatibility
2
2
Contamination
1
1
Device Reprocessing Problem
1
1
Accessory Incompatible
1
1
Material Protrusion/Extrusion
1
1
Unintended Collision
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1948
1948
No Consequences Or Impact To Patient
355
355
Insufficient Information
112
112
Foreign Body In Patient
70
70
No Known Impact Or Consequence To Patient
41
41
Urinary Tract Infection
30
30
Sepsis
20
20
Perforation
19
19
No Patient Involvement
16
16
Pain
14
14
Hemorrhage/Bleeding
11
11
Hematuria
10
10
Fever
9
9
Inflammation
8
8
Device Embedded In Tissue or Plaque
7
7
Unspecified Tissue Injury
7
7
Laceration(s)
6
6
Swelling/ Edema
5
5
No Code Available
5
5
Renal Failure
5
5
Abscess
3
3
Bacterial Infection
3
3
No Information
3
3
Unspecified Infection
3
3
Bowel Perforation
3
3
Obstruction/Occlusion
2
2
Vomiting
2
2
Urinary Retention
2
2
Septic Shock
2
2
Confusion/ Disorientation
2
2
Nausea
2
2
Respiratory Failure
1
1
Sleep Dysfunction
1
1
Choking
1
1
Abdominal Cramps
1
1
Fungal Infection
1
1
Injury
1
1
Anxiety
1
1
Urethral Stenosis/Stricture
1
1
Pancreatitis
1
1
Gastrointestinal Hemorrhage
1
1
Unspecified Respiratory Problem
1
1
Unspecified Immune System Problem
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Constipation
1
1
Multiple Organ Failure
1
1
Ambulation Difficulties
1
1
Tissue Breakdown
1
1
Abdominal Distention
1
1
Headache
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Philips North America, LLC
II
Apr-13-2022
2
Wilson-Cook Medical Inc.
II
Jul-28-2023
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