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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device dislodger, stone, basket, ureteral, metal
Product CodeFFL
Regulation Number 876.4680
Device Class 2


Premarket Reviews
ManufacturerDecision
CALCULA TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 351 351
2020 375 375
2021 358 358
2022 426 426
2023 593 593
2024 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 1034 1034
Break 503 503
Detachment of Device or Device Component 133 133
Material Separation 123 123
Material Deformation 101 101
Adverse Event Without Identified Device or Use Problem 88 88
Fracture 79 79
Material Split, Cut or Torn 59 59
Material Twisted/Bent 57 57
Device Damaged Prior to Use 30 30
Device Contaminated During Manufacture or Shipping 24 24
Difficult to Fold, Unfold or Collapse 23 23
Material Fragmentation 20 20
Defective Device 16 16
Deformation Due to Compressive Stress 13 13
Tear, Rip or Hole in Device Packaging 12 12
Difficult to Remove 11 11
Nonstandard Device 9 9
Unsealed Device Packaging 9 9
Device Contamination with Chemical or Other Material 9 9
Loss of or Failure to Bond 8 8
Use of Device Problem 8 8
Appropriate Term/Code Not Available 7 7
Physical Resistance/Sticking 6 6
Contamination /Decontamination Problem 6 6
Material Frayed 5 5
Disconnection 5 5
Entrapment of Device 5 5
Mechanical Problem 5 5
Difficult to Advance 5 5
Mechanical Jam 5 5
Solder Joint Fracture 4 4
Off-Label Use 4 4
Component Missing 3 3
Loose or Intermittent Connection 3 3
Accessory Incompatible 3 3
Packaging Problem 3 3
Sharp Edges 3 3
Insufficient Information 3 3
Component Misassembled 3 3
Separation Problem 2 2
Device Handling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device-Device Incompatibility 2 2
Peeled/Delaminated 2 2
Activation, Positioning or Separation Problem 2 2
Structural Problem 1 1
Failure to Advance 1 1
Retraction Problem 1 1
Material Rupture 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Stretched 1 1
Unraveled Material 1 1
Unintended Collision 1 1
Misassembled 1 1
Flaked 1 1
Failure to Capture 1 1
Contamination 1 1
Incorrect Measurement 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Misassembly by Users 1 1
Material Protrusion/Extrusion 1 1
Migration 1 1
Device Fell 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1246 1246
No Consequences Or Impact To Patient 614 614
No Known Impact Or Consequence To Patient 115 115
Insufficient Information 83 83
Foreign Body In Patient 59 59
No Patient Involvement 30 30
Urinary Tract Infection 27 27
Perforation 16 16
Sepsis 13 13
Pain 12 12
Device Embedded In Tissue or Plaque 9 9
No Information 7 7
Inflammation 6 6
Hemorrhage/Bleeding 5 5
Renal Failure 5 5
No Code Available 5 5
Swelling/ Edema 5 5
Hematuria 3 3
Laceration(s) 3 3
Bacterial Infection 3 3
Unspecified Infection 2 2
Nausea 2 2
Vomiting 2 2
Injury 2 2
Urinary Retention 2 2
Confusion/ Disorientation 2 2
Obstruction/Occlusion 2 2
Unspecified Tissue Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bowel Perforation 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
Choking 1 1
Respiratory Failure 1 1
Sleep Dysfunction 1 1
Abdominal Cramps 1 1
Ambulation Difficulties 1 1
Abdominal Distention 1 1
Constipation 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Immune System Problem 1 1
Unspecified Respiratory Problem 1 1
Gastrointestinal Hemorrhage 1 1
Pancreatitis 1 1
Localized Skin Lesion 1 1
Fungal Infection 1 1
Rupture 1 1
Anxiety 1 1
Burning Sensation 1 1
Abnormal Vaginal Discharge 1 1
Internal Organ Perforation 1 1
Pneumonia 1 1
Septic Shock 1 1
Tissue Damage 1 1
Myocardial Infarction 1 1
Abdominal Pain 1 1
Abscess 1 1
Anaphylactic Shock 1 1
Autoimmune Disorder 1 1
Erosion 1 1
Stroke/CVA 1 1
Death 1 1
Diarrhea 1 1
Emotional Changes 1 1
Extravasation 1 1
Fatigue 1 1
Fever 1 1
Fistula 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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