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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
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 348 348

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 215 215
Break 132 132
Adverse Event Without Identified Device or Use Problem 129 129
No Display/Image 115 115
Device Reprocessing Problem 74 74
Poor Quality Image 40 40
Contamination /Decontamination Problem 37 37
Erratic or Intermittent Display 35 35
Electrical /Electronic Property Problem 31 31
Failure to Power Up 25 25
Insufficient Information 24 24
Detachment of Device or Device Component 23 23
Peeled/Delaminated 14 14
Power Problem 12 12
Material Split, Cut or Torn 12 12
Material Separation 12 12
Fluid Leak 12 12
Defective Device 10 10
Loose or Intermittent Connection 10 10
Display or Visual Feedback Problem 9 9
Appropriate Term/Code Not Available 9 9
Output Problem 9 9
Crack 8 8
Image Display Error/Artifact 8 8
Connection Problem 8 8
Device Contamination with Chemical or Other Material 8 8
Material Integrity Problem 8 8
Failure to Clean Adequately 7 7
Detachment Of Device Component 6 6
Corroded 5 5
Improper or Incorrect Procedure or Method 5 5
Material Deformation 5 5
Fracture 5 5
Material Fragmentation 5 5
Mechanical Problem 5 5
Difficult to Remove 5 5
Material Disintegration 4 4
Problem with Sterilization 4 4
Device Fell 4 4
Defective Component 4 4
Leak/Splash 4 4
Arcing 3 3
Optical Problem 3 3
Use of Device Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
No Apparent Adverse Event 3 3
Device Dislodged or Dislocated 2 2
Material Protrusion/Extrusion 2 2
Device Handling Problem 2 2
Material Perforation 2 2
Component Missing 2 2
No Device Output 2 2
Degraded 2 2
Complete Loss of Power 2 2
Key or Button Unresponsive/not Working 2 2
Material Rupture 2 2
Electrical Power Problem 2 2
Fail-Safe Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination With Biological Material 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Unsafe to Use in Environment 1 1
Unraveled Material 1 1
Product Quality Problem 1 1
Device Damaged Prior to Use 1 1
Misconnection 1 1
Entrapment of Device 1 1
Material Erosion 1 1
Material Discolored 1 1
Disconnection 1 1
Display Difficult to Read 1 1
Contamination 1 1
Intermittent Continuity 1 1
Failure To Adhere Or Bond 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Scratched Material 1 1
Unintended Movement 1 1
Physical Resistance/Sticking 1 1
Electromagnetic Interference 1 1
Complete Blockage 1 1
Collapse 1 1
Overheating of Device 1 1
Particulates 1 1
Loss of Power 1 1
Hole In Material 1 1
Structural Problem 1 1
Split 1 1
Sparking 1 1
Folded 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or SeparationProblem 1 1
Material Too Rigid or Stiff 1 1
Noise, Audible 1 1
Unclear Information 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 244 244
No Clinical Signs, Symptoms or Conditions 238 238
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
Burn(s) 5 5
Fever 5 5
Electric Shock 5 5
Injury 5 5
Patient Problem/Medical Problem 4 4
Urinary Retention 4 4
Device Embedded In Tissue or Plaque 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blood Loss 2 2
Laceration(s) 2 2
Pain 1 1
Local Reaction 1 1
Shock 1 1
Tissue Damage 1 1
Syncope 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Full thickness (Third Degree) Burn 1 1
Needle Stick/Puncture 1 1
Burn, Thermal 1 1
No Code Available 1 1
Unspecified Kidney or Urinary Problem 1 1
Unspecified Tissue Injury 1 1
Irritation 1 1
Perforation 1 1
Malaise 1 1
Numbness 1 1
Hearing Loss 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Discoloration 1 1
Swelling 1 1
Chills 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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