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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cystoscope and accessories, flexible/rigid
Regulation Description Endoscope and accessories.
Definition To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeFAJ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 2
HENKE-SASS, WOLF GMBH
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOLACE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UROVIU CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
  1.  K171500  Uro-V Cystoscope
  2.  K182876  Uro-N Cystoscope
  3.  K202921  Uro-G Cystoscope
UVISION360 INC.
  SUBSTANTIALLY EQUIVALENT 1
UVISION360, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 75 75
2017 79 79
2018 79 79
2019 101 101
2020 339 339
2021 388 388

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 221 221
Break 135 135
Adverse Event Without Identified Device or Use Problem 129 129
No Display/Image 122 122
Device Reprocessing Problem 79 79
Poor Quality Image 42 42
Contamination /Decontamination Problem 38 38
Electrical /Electronic Property Problem 36 36
Erratic or Intermittent Display 35 35
Failure to Power Up 28 28
Insufficient Information 24 24
Detachment of Device or Device Component 23 23
Material Separation 15 15
Peeled/Delaminated 14 14
Fluid Leak 13 13
Material Split, Cut or Torn 12 12
Power Problem 12 12
Defective Device 11 11
Loose or Intermittent Connection 11 11
Display or Visual Feedback Problem 10 10
Output Problem 9 9
Appropriate Term/Code Not Available 9 9
Connection Problem 8 8
Material Integrity Problem 8 8
Crack 8 8
Device Contamination with Chemical or Other Material 8 8
Image Display Error/Artifact 8 8
Failure to Clean Adequately 7 7
Detachment Of Device Component 6 6
Fracture 6 6
Difficult to Remove 5 5
Corroded 5 5
Improper or Incorrect Procedure or Method 5 5
Defective Component 5 5
Component Missing 5 5
Material Deformation 5 5
Material Fragmentation 5 5
Mechanical Problem 5 5
Material Rupture 4 4
Leak/Splash 4 4
Device Fell 4 4
Problem with Sterilization 4 4
Material Disintegration 4 4
Use of Device Problem 3 3
No Apparent Adverse Event 3 3
Optical Problem 3 3
Unintended Movement 3 3
Arcing 3 3
Labelling, Instructions for Use or Training Problem 3 3
No Device Output 2 2
Material Perforation 2 2
Complete Loss of Power 2 2
Material Protrusion/Extrusion 2 2
Device Handling Problem 2 2
Device Dislodged or Dislocated 2 2
Degraded 2 2
Deformation Due to Compressive Stress 2 2
Electrical Power Problem 2 2
Key or Button Unresponsive/not Working 2 2
Fail-Safe Problem 1 1
Unraveled Material 1 1
Circuit Failure 1 1
Intermittent Continuity 1 1
Activation, Positioning or SeparationProblem 1 1
Structural Problem 1 1
Particulates 1 1
Smoking 1 1
Sparking 1 1
Material Twisted/Bent 1 1
Failure To Adhere Or Bond 1 1
Contamination 1 1
Material Discolored 1 1
Display Difficult to Read 1 1
Misconnection 1 1
Product Quality Problem 1 1
Unclear Information 1 1
Misassembly by Users 1 1
Material Too Rigid or Stiff 1 1
Hole In Material 1 1
Loss of Power 1 1
Complete Blockage 1 1
Electromagnetic Interference 1 1
Folded 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination With Biological Material 1 1
Physical Resistance/Sticking 1 1
Device Damaged Prior to Use 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Unsafe to Use in Environment 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Scratched Material 1 1
Entrapment of Device 1 1
Material Erosion 1 1
Thermal Decomposition of Device 1 1
Disconnection 1 1
Split 1 1
Packaging Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 278 278
No Consequences Or Impact To Patient 244 244
No Known Impact Or Consequence To Patient 143 143
No Patient Involvement 136 136
Unspecified Infection 117 117
Bacterial Infection 70 70
Urinary Tract Infection 34 34
Sepsis 23 23
Inflammation 13 13
Foreign Body In Patient 9 9
No Information 7 7
Insufficient Information 7 7
Hematuria 6 6
Fever 5 5
Injury 5 5
Electric Shock 5 5
Burn(s) 5 5
Urinary Retention 4 4
Patient Problem/Medical Problem 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Device Embedded In Tissue or Plaque 3 3
Blood Loss 2 2
Laceration(s) 2 2
Syncope 1 1
Full thickness (Third Degree) Burn 1 1
Unspecified Kidney or Urinary Problem 1 1
Skin Discoloration 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Death 1 1
Shock 1 1
Tissue Damage 1 1
Swelling 1 1
Chills 1 1
Malaise 1 1
Needle Stick/Puncture 1 1
Burn, Thermal 1 1
Pain 1 1
Perforation 1 1
Numbness 1 1
Hearing Loss 1 1
Hypersensitivity/Allergic reaction 1 1
Irritation 1 1
Hemorrhage/Bleeding 1 1
Local Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
2 Medivators, Inc. II Apr-23-2020
3 Pentax Medical Company II Jun-28-2016
4 Pentax of America Inc II Feb-14-2018
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