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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 426 426
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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