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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
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 149 149

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 1078 1078
Break 525 525
Detachment of Device or Device Component 142 142
Material Separation 128 128
Material Deformation 103 103
Adverse Event Without Identified Device or Use Problem 90 90
Fracture 81 81
Material Split, Cut or Torn 66 66
Material Twisted/Bent 62 62
Device Damaged Prior to Use 31 31
Device Contaminated During Manufacture or Shipping 27 27
Difficult to Fold, Unfold or Collapse 24 24
Material Fragmentation 21 21
Loss of or Failure to Bond 20 20
Deformation Due to Compressive Stress 18 18
Defective Device 16 16
Tear, Rip or Hole in Device Packaging 12 12
Difficult to Remove 11 11
Unsealed Device Packaging 10 10
Nonstandard Device 9 9
Device Contamination with Chemical or Other Material 9 9
Use of Device Problem 8 8
Contamination /Decontamination Problem 7 7
Appropriate Term/Code Not Available 7 7
Physical Resistance/Sticking 6 6
Mechanical Jam 5 5
Difficult to Advance 5 5
Mechanical Problem 5 5
Disconnection 5 5
Entrapment of Device 5 5
Material Frayed 5 5
Solder Joint Fracture 4 4
Off-Label Use 4 4
Component Missing 3 3
Accessory Incompatible 3 3
Loose or Intermittent Connection 3 3
Packaging Problem 3 3
Sharp Edges 3 3
Component Misassembled 3 3
Insufficient Information 3 3
Separation Problem 2 2
Device Handling Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device-Device Incompatibility 2 2
Activation, Positioning or Separation Problem 2 2
Peeled/Delaminated 2 2
Retraction Problem 1 1
Material Rupture 1 1
Stretched 1 1
Unraveled Material 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Structural Problem 1 1
Failure to Advance 1 1
Incorrect Measurement 1 1
Flaked 1 1
Misassembled 1 1
Unintended Collision 1 1
Failure to Capture 1 1
Contamination 1 1
Difficult to Insert 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
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1339 1339
No Consequences Or Impact To Patient 614 614
No Known Impact Or Consequence To Patient 115 115
Insufficient Information 88 88
Foreign Body In Patient 61 61
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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