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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
THS INTERNATIONAL, INC. D/B/A ACCORDION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  1.  K172299  Accordion Piccolo Stone Management Device

MDR Year MDR Reports MDR Events
2017 517 517
2018 428 428
2019 351 351
2020 375 375
2021 358 358
2022 233 233

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 909 909
Break 662 662
Material Separation 153 153
Device Operates Differently Than Expected 109 109
Detachment of Device or Device Component 90 90
Fracture 80 80
Material Deformation 74 74
Device Damaged Prior to Use 45 45
Material Twisted/Bent 44 44
Material Split, Cut or Torn 43 43
Adverse Event Without Identified Device or Use Problem 24 24
Detachment Of Device Component 24 24
Difficult or Delayed Positioning 23 23
Material Fragmentation 20 20
Mechanical Problem 18 18
Defective Device 18 18
Difficult to Fold, Unfold or Collapse 17 17
Device Contamination with Chemical or Other Material 14 14
Device Contaminated During Manufacture or Shipping 14 14
Tear, Rip or Hole in Device Packaging 13 13
Difficult to Remove 12 12
Kinked 10 10
Unsealed Device Packaging 10 10
Device Inoperable 10 10
Device Operational Issue 10 10
Mechanical Jam 10 10
Physical Resistance/Sticking 9 9
Appropriate Term/Code Not Available 9 9
Deformation Due to Compressive Stress 9 9
Use of Device Problem 9 9
Component Missing 9 9
Loose or Intermittent Connection 9 9
Bent 9 9
Entrapment of Device 8 8
Contamination /Decontamination Problem 8 8
Retraction Problem 7 7
Off-Label Use 7 7
Material Frayed 6 6
Material Rupture 5 5
Improper or Incorrect Procedure or Method 5 5
Solder Joint Fracture 4 4
Structural Problem 4 4
Disconnection 4 4
Insufficient Information 4 4
Torn Material 3 3
Packaging Problem 3 3
Accessory Incompatible 3 3
Unintended Collision 3 3
Out-Of-Box Failure 2 2
Failure to Advance 2 2
Split 2 2
Sticking 2 2
Stretched 2 2
Connection Problem 2 2
Device Packaging Compromised 2 2
Device-Device Incompatibility 2 2
Difficult to Advance 2 2
Device Dislodged or Dislocated 2 2
Peeled/Delaminated 2 2
Migration or Expulsion of Device 2 2
Misassembled 2 2
Material Protrusion/Extrusion 2 2
Device Handling Problem 2 2
Component Misassembled 2 2
Separation Problem 2 2
Device Fell 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Naturally Worn 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Nonstandard Device 1 1
Difficult to Insert 1 1
Product Quality Problem 1 1
Positioning Failure 1 1
Material Discolored 1 1
Flaked 1 1
Contamination 1 1
Crack 1 1
Degraded 1 1
Failure to Capture 1 1
Coiled 1 1
Collapse 1 1
Device Damaged by Another Device 1 1
Activation, Positioning or SeparationProblem 1 1
Device Or Device Fragments Location Unknown 1 1
Device Markings/Labelling Problem 1 1
Unraveled Material 1 1
Failure to Unfold or Unwrap 1 1
Microbial Contamination of Device 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1168 1168
No Clinical Signs, Symptoms or Conditions 513 513
No Known Impact Or Consequence To Patient 346 346
No Patient Involvement 178 178
Foreign Body In Patient 59 59
Insufficient Information 43 43
No Information 40 40
Device Embedded In Tissue or Plaque 24 24
No Code Available 17 17
Urinary Tract Infection 12 12
Obstruction/Occlusion 6 6
Perforation 6 6
Hemorrhage/Bleeding 4 4
Sepsis 3 3
Inflammation 3 3
Laceration(s) 3 3
Pain 3 3
Tissue Damage 3 3
Injury 3 3
Discomfort 2 2
Unspecified Tissue Injury 2 2
Internal Organ Perforation 2 2
Renal Failure 2 2
Extravasation 2 2
Bacterial Infection 2 2
Death 1 1
Edema 1 1
Anaphylactic Shock 1 1
Autoimmune Disorder 1 1
Fistula 1 1
Unspecified Infection 1 1
Septic Shock 1 1
Nausea 1 1
Hematuria 1 1
Patient Problem/Medical Problem 1 1
Complaint, Ill-Defined 1 1
Vomiting 1 1
Rupture 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips North America, LLC II Apr-13-2022
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