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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dislodger, stone, basket, ureteral, metal
Regulation Description Ureteral stone dislodger.
Product CodeFFL
Regulation Number 876.4680
Device Class 2

MDR Year MDR Reports MDR Events
2020 375 375
2021 358 358
2022 426 427
2023 593 593
2024 606 607
2025 420 421

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 1274 1274
Break 721 722
Detachment of Device or Device Component 225 225
Adverse Event Without Identified Device or Use Problem 153 153
Material Deformation 147 147
Material Separation 138 138
Material Split, Cut or Torn 126 126
Fracture 122 122
Loss of or Failure to Bond 118 119
Material Twisted/Bent 70 70
Deformation Due to Compressive Stress 42 42
Device Contaminated During Manufacture or Shipping 38 38
Difficult to Fold, Unfold or Collapse 34 34
Material Fragmentation 34 34
Device Damaged Prior to Use 31 31
Unsealed Device Packaging 16 16
Nonstandard Device 13 13
Defective Device 13 13
Difficult to Remove 12 12
Use of Device Problem 10 10
Device Contamination with Chemical or Other Material 9 9
Tear, Rip or Hole in Device Packaging 9 9
Appropriate Term/Code Not Available 6 6
Insufficient Information 6 6
Device Damaged by Another Device 6 6
Contamination /Decontamination Problem 6 6
Disconnection 5 5
Component Misassembled 4 4
Packaging Problem 4 4
Material Frayed 4 4
Difficult to Advance 4 4
Entrapment of Device 4 4
Physical Resistance/Sticking 4 4
Activation, Positioning or Separation Problem 3 3
Loose or Intermittent Connection 3 3
Component Missing 3 3
Defective Component 3 3
Sharp Edges 3 3
Mechanical Problem 3 3
Difficult to Insert 2 2
Device-Device Incompatibility 2 2
Off-Label Use 2 2
Device Handling Problem 2 2
Peeled/Delaminated 2 2
Unintended Collision 1 1
Improper or Incorrect Procedure or Method 1 1
Material Too Soft/Flexible 1 1
Device Reprocessing Problem 1 1
Separation Problem 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2167 2168
No Consequences Or Impact To Patient 355 355
Insufficient Information 114 114
Foreign Body In Patient 75 76
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
Laceration(s) 8 8
Device Embedded In Tissue or Plaque 7 7
Unspecified Tissue Injury 7 7
No Code Available 5 5
Swelling/ Edema 5 5
Renal Failure 5 5
Unspecified Infection 3 3
Bowel Perforation 3 3
No Information 3 3
Bacterial Infection 3 3
Abscess 3 3
Obstruction/Occlusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Confusion/ Disorientation 2 2
Nausea 2 2
Septic Shock 2 2
Urinary Retention 2 2
Vomiting 2 2
Ambulation Difficulties 1 1
Fistula 1 1
Tissue Breakdown 1 1
Respiratory Failure 1 1
Constipation 1 1
Headache 1 1
Erosion 1 1
Abdominal Pain 1 1
Unspecified Respiratory Problem 1 1
Myocardial Infarction 1 1
Anxiety 1 1
Extravasation 1 1
Anaphylactic Shock 1 1
Pneumonia 1 1
Choking 1 1
Sleep Dysfunction 1 1
Diarrhea 1 1
Stroke/CVA 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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