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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 149 149

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 1411 1411
Break 950 950
Material Separation 203 203
Detachment of Device or Device Component 192 192
Device Operates Differently Than Expected 117 117
Material Deformation 110 110
Fracture 97 97
Adverse Event Without Identified Device or Use Problem 97 97
Material Twisted/Bent 72 72
Material Split, Cut or Torn 67 67
Device Damaged Prior to Use 59 59
Detachment Of Device Component 53 53
Difficult to Remove 30 30
Device Contaminated During Manufacture or Shipping 29 29
Material Fragmentation 28 28
Difficult to Fold, Unfold or Collapse 24 24
Difficult or Delayed Positioning 23 23
Device Contamination with Chemical or Other Material 22 22
Tear, Rip or Hole in Device Packaging 21 21
Loss of or Failure to Bond 20 20
Mechanical Problem 20 20
Defective Device 19 19
Deformation Due to Compressive Stress 19 19
Unsealed Device Packaging 15 15
Mechanical Jam 12 12
Loose or Intermittent Connection 12 12
Device Inoperable 12 12
Component Missing 11 11
Use of Device Problem 10 10
Appropriate Term/Code Not Available 10 10
Device Operational Issue 10 10
Kinked 10 10
Nonstandard Device 10 10
Device Packaging Compromised 10 10
Physical Resistance/Sticking 10 10
Entrapment of Device 9 9
Bent 9 9
Contamination /Decontamination Problem 9 9
Material Frayed 8 8
Disconnection 8 8
Torn Material 8 8
Off-Label Use 8 8
Retraction Problem 7 7
Improper or Incorrect Procedure or Method 7 7
Unintended Collision 6 6
Packaging Problem 5 5
Difficult to Advance 5 5
Material Rupture 5 5
Component Falling 4 4
Insufficient Information 4 4
Solder Joint Fracture 4 4
Structural Problem 4 4
Device Dislodged or Dislocated 3 3
Activation, Positioning or Separation Problem 3 3
Component Misassembled 3 3
Migration or Expulsion of Device 3 3
Device Or Device Fragments Location Unknown 3 3
Sharp Edges 3 3
Accessory Incompatible 3 3
Sticking 3 3
Peeled/Delaminated 3 3
Device-Device Incompatibility 2 2
Separation Failure 2 2
Device Handling Problem 2 2
Material Protrusion/Extrusion 2 2
Out-Of-Box Failure 2 2
Difficult to Insert 2 2
Component(s), broken 2 2
Separation Problem 2 2
Stretched 2 2
Split 2 2
Failure to Advance 2 2
Misassembled 2 2
Connection Problem 2 2
Unraveled Material 2 2
Therapeutic or Diagnostic Output Failure 2 2
Activation Problem 1 1
Incorrect Measurement 1 1
Degraded 1 1
Coiled 1 1
Product Quality Problem 1 1
Migration 1 1
Material Integrity Problem 1 1
Contamination 1 1
Device Fell 1 1
Failure to Capture 1 1
Defective Component 1 1
Material Discolored 1 1
Failure to Unfold or Unwrap 1 1
Device Slipped 1 1
Microbial Contamination of Device 1 1
Crack 1 1
Naturally Worn 1 1
Material Too Soft/Flexible 1 1
Collapse 1 1
Device Markings/Labelling Problem 1 1
Positioning Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Mechanics Altered 1 1
Flaked 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 1291 1291
No Known Impact Or Consequence To Patient 392 392
No Patient Involvement 188 188
Foreign Body In Patient 93 93
Insufficient Information 88 88
No Information 51 51
No Code Available 35 35
Device Embedded In Tissue or Plaque 32 32
Urinary Tract Infection 27 27
Perforation 20 20
Pain 15 15
Sepsis 13 13
Foreign body, removal of 11 11
Injury 8 8
Hemorrhage/Bleeding 8 8
Inflammation 7 7
Obstruction/Occlusion 7 7
Hematuria 6 6
Swelling/ Edema 5 5
Laceration(s) 5 5
Renal Failure 5 5
Tissue Damage 4 4
Unspecified Infection 3 3
Extravasation 3 3
Bacterial Infection 3 3
Urinary Retention 2 2
Vomiting 2 2
Nausea 2 2
Internal Organ Perforation 2 2
Unspecified Tissue Injury 2 2
Confusion/ Disorientation 2 2
Rupture 2 2
Nonresorbable materials, unretrieved in body 2 2
Discomfort 2 2
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
Fungal Infection 1 1
Abdominal Distention 1 1
Bowel Perforation 1 1
Tissue Breakdown 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
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

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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