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

MDR Year MDR Reports MDR Events
2017 517 517
2018 428 428
2019 351 351
2020 375 375
2021 358 358
2022 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 862 862
Break 643 643
Material Separation 150 150
Device Operates Differently Than Expected 109 109
Detachment of Device or Device Component 87 87
Fracture 80 80
Material Deformation 72 72
Device Damaged Prior to Use 44 44
Material Twisted/Bent 40 40
Material Split, Cut or Torn 40 40
Detachment Of Device Component 24 24
Difficult or Delayed Positioning 23 23
Material Fragmentation 20 20
Mechanical Problem 18 18
Defective Device 17 17
Difficult to Fold, Unfold or Collapse 16 16
Device Contaminated During Manufacture or Shipping 14 14
Device Contamination with Chemical or Other Material 13 13
Tear, Rip or Hole in Device Packaging 13 13
Difficult to Remove 11 11
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
Contamination /Decontamination Problem 8 8
Entrapment of Device 7 7
Retraction Problem 7 7
Off-Label Use 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Material Rupture 5 5
Improper or Incorrect Procedure or Method 5 5
Solder Joint Fracture 4 4
Structural Problem 4 4
Material Frayed 4 4
Insufficient Information 4 4
Torn Material 3 3
Packaging Problem 3 3
Disconnection 3 3
Accessory Incompatible 3 3
Migration or Expulsion of Device 2 2
Misassembled 2 2
Peeled/Delaminated 2 2
Failure to Advance 2 2
Split 2 2
Unintended Collision 2 2
Out-Of-Box Failure 2 2
Sticking 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
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
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
Stretched 1 1
Unraveled Material 1 1
Failure to Unfold or Unwrap 1 1
Microbial Contamination of Device 1 1
Separation Failure 1 1
Product Quality Problem 1 1
Nonstandard Device 1 1
Difficult to Insert 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

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 440 440
No Known Impact Or Consequence To Patient 346 346
No Patient Involvement 178 178
Foreign Body In Patient 56 56
Insufficient Information 41 41
No Information 40 40
Device Embedded In Tissue or Plaque 23 23
No Code Available 17 17
Obstruction/Occlusion 6 6
Perforation 4 4
Hemorrhage/Bleeding 3 3
Tissue Damage 3 3
Inflammation 3 3
Injury 3 3
Unspecified Tissue Injury 2 2
Discomfort 2 2
Laceration(s) 2 2
Internal Organ Perforation 2 2
Pain 2 2
Bacterial Infection 2 2
Extravasation 2 2
Fistula 1 1
Death 1 1
Edema 1 1
Anaphylactic Shock 1 1
Rupture 1 1
Unspecified Infection 1 1
Septic Shock 1 1
Complaint, Ill-Defined 1 1
Hematuria 1 1
Patient Problem/Medical Problem 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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