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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
PERCUTANEOUS SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
THS INTERNATIONAL, INC. D/B/A ACCORDION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 71 71
2015 79 79
2016 88 88
2017 517 517
2018 428 428
2019 351 351
2020 375 375
2021 358 358
2022 426 426
2023 593 593
2024 259 259

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 1470 1470
Break 967 967
Detachment of Device or Device Component 222 222
Material Separation 207 207
Material Deformation 119 119
Device Operates Differently Than Expected 117 117
Fracture 115 115
Adverse Event Without Identified Device or Use Problem 102 102
Material Twisted/Bent 77 77
Material Split, Cut or Torn 72 72
Device Damaged Prior to Use 61 61
Detachment Of Device Component 53 53
Loss of or Failure to Bond 33 33
Material Fragmentation 31 31
Difficult to Remove 30 30
Device Contaminated During Manufacture or Shipping 30 30
Difficult to Fold, Unfold or Collapse 26 26
Difficult or Delayed Positioning 23 23
Device Contamination with Chemical or Other Material 22 22
Tear, Rip or Hole in Device Packaging 21 21
Mechanical Problem 20 20
Defective Device 19 19
Deformation Due to Compressive Stress 19 19
Unsealed Device Packaging 15 15
Loose or Intermittent Connection 12 12
Device Inoperable 12 12
Mechanical Jam 12 12
Component Missing 11 11
Use of Device Problem 10 10
Device Operational Issue 10 10
Device Packaging Compromised 10 10
Kinked 10 10
Nonstandard Device 10 10
Physical Resistance/Sticking 10 10
Appropriate Term/Code Not Available 10 10
Entrapment of Device 9 9
Bent 9 9
Contamination /Decontamination Problem 9 9
Off-Label Use 8 8
Disconnection 8 8
Material Frayed 8 8
Torn Material 8 8
Improper or Incorrect Procedure or Method 7 7
Retraction Problem 7 7
Unintended Collision 6 6
Material Rupture 5 5
Packaging Problem 5 5
Difficult to Advance 5 5
Insufficient Information 4 4
Solder Joint Fracture 4 4
Structural Problem 4 4
Peeled/Delaminated 4 4
Component Falling 4 4
Accessory Incompatible 3 3
Migration or Expulsion of Device 3 3
Device Or Device Fragments Location Unknown 3 3
Activation, Positioning or Separation Problem 3 3
Sticking 3 3
Sharp Edges 3 3
Component Misassembled 3 3
Device Dislodged or Dislocated 3 3
Material Protrusion/Extrusion 2 2
Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Handling Problem 2 2
Stretched 2 2
Unraveled Material 2 2
Out-Of-Box Failure 2 2
Defective Component 2 2
Device-Device Incompatibility 2 2
Connection Problem 2 2
Failure to Advance 2 2
Split 2 2
Separation Failure 2 2
Misassembled 2 2
Difficult to Insert 2 2
Component(s), broken 2 2
Failure to Capture 1 1
Coiled 1 1
Collapse 1 1
Contamination 1 1
Crack 1 1
Degraded 1 1
Flaked 1 1
Positioning Failure 1 1
Material Discolored 1 1
Incorrect Measurement 1 1
Product Quality Problem 1 1
Failure to Align 1 1
Device Damaged by Another Device 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Microbial Contamination of Device 1 1
Wire(s), breakage of 1 1
Failure to Unfold or Unwrap 1 1
Device Slipped 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 1446 1446
No Consequences Or Impact To Patient 1291 1291
No Known Impact Or Consequence To Patient 392 392
No Patient Involvement 188 188
Foreign Body In Patient 93 93
Insufficient Information 90 90
No Information 51 51
No Code Available 35 35
Device Embedded In Tissue or Plaque 32 32
Urinary Tract Infection 28 28
Perforation 20 20
Pain 15 15
Sepsis 13 13
Foreign body, removal of 11 11
Hemorrhage/Bleeding 10 10
Injury 8 8
Hematuria 7 7
Obstruction/Occlusion 7 7
Inflammation 7 7
Laceration(s) 5 5
Renal Failure 5 5
Swelling/ Edema 5 5
Tissue Damage 4 4
Unspecified Infection 4 4
Extravasation 3 3
Bacterial Infection 3 3
Unspecified Tissue Injury 3 3
Rupture 2 2
Nonresorbable materials, unretrieved in body 2 2
Discomfort 2 2
Confusion/ Disorientation 2 2
Urinary Retention 2 2
Vomiting 2 2
Nausea 2 2
Internal Organ Perforation 2 2
Pneumonia 1 1
Septic Shock 1 1
Burning Sensation 1 1
Unknown (for use when the patient's condition is not known) 1 1
Abnormal Vaginal Discharge 1 1
Erosion 1 1
Stroke/CVA 1 1
Death 1 1
Diarrhea 1 1
Edema 1 1
Emotional Changes 1 1
Abdominal Pain 1 1
Abscess 1 1
Anaphylactic Shock 1 1
Autoimmune Disorder 1 1
Fatigue 1 1
Fever 1 1
Fistula 1 1
Headache 1 1
Myocardial Infarction 1 1
Fungal Infection 1 1
Abdominal Distention 1 1
Bowel Perforation 1 1
Tissue Breakdown 1 1
Complaint, Ill-Defined 1 1
Anxiety 1 1
Choking 1 1
Respiratory Failure 1 1
Sleep Dysfunction 1 1
Abdominal Cramps 1 1
Ambulation Difficulties 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 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

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Oct-31-2014
2 Philips North America, LLC II Apr-13-2022
3 Sterilmed Inc II Jan-13-2009
4 Wilson-Cook Medical Inc. II Jul-28-2023
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