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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
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ SE & CO KG
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 75 75
2017 79 79
2018 79 79
2019 101 101
2020 339 339
2021 94 94

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 187 187
Adverse Event Without Identified Device or Use Problem 109 109
Break 93 93
No Display/Image 69 69
Device Reprocessing Problem 52 52
Contamination /Decontamination Problem 32 32
Poor Quality Image 31 31
Endoscope 29 29
Insufficient Information 24 24
Erratic or Intermittent Display 18 18
Detachment of Device or Device Component 17 17
Failure to Power Up 15 15
Electrical /Electronic Property Problem 15 15
Fluid Leak 11 11
Defective Device 10 10
Output Problem 9 9
Appropriate Term/Code Not Available 9 9
Tip 8 8
Peeled/Delaminated 8 8
Device Contamination with Chemical or Other Material 8 8
Power Problem 8 8
Material Integrity Problem 7 7
Failure to Clean Adequately 7 7
Loose or Intermittent Connection 6 6
Detachment Of Device Component 6 6
Material Split, Cut or Torn 6 6
Display or Visual Feedback Problem 6 6
Electrode 5 5
Difficult to Remove 5 5
Image Display Error/Artifact 5 5
Connection Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Material Deformation 4 4
Leak/Splash 4 4
Device Fell 4 4
Material Separation 4 4
Problem with Sterilization 4 4
Fracture 4 4
Material Fragmentation 4 4
Mechanical Problem 3 3
Material Disintegration 3 3
No Apparent Adverse Event 3 3
Corroded 3 3
Defective Component 2 2
Electrical Power Problem 2 2
Material Rupture 2 2
Complete Loss of Power 2 2
Material Perforation 2 2
Device Handling Problem 2 2
Device Dislodged or Dislocated 2 2
Material Protrusion/Extrusion 2 2
Labelling, Instructions for Use or Training Problem 2 2
No Device Output 2 2
Crack 2 2
Degraded 1 1
Electromagnetic Interference 1 1
Hole In Material 1 1
Cord 1 1
Cap 1 1
Complete Blockage 1 1
Collapse 1 1
Overheating of Device 1 1
Particulates 1 1
Loss of Power 1 1
Use of Device Problem 1 1
Component Missing 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 Twisted/Bent 1 1
Naturally Worn 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Unclear Information 1 1
Misassembly by Users 1 1
Knife 1 1
Scratched Material 1 1
Cannula 1 1
Physical Resistance/Sticking 1 1
Device Damaged Prior to Use 1 1
Device Contamination With Biological Material 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Unsafe to Use in Environment 1 1
Fail-Safe Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Optical Problem 1 1
Material Discolored 1 1
Disconnection 1 1
Intermittent Continuity 1 1
Pin 1 1
Failure To Adhere Or Bond 1 1
Thermal Decomposition of Device 1 1
Circuit Failure 1 1
Product Quality Problem 1 1
Entrapment of Device 1 1
Material Erosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 241 241
No Known Impact Or Consequence To Patient 143 143
No Patient Involvement 135 135
Unspecified Infection 115 115
Bacterial Infection 57 57
Sepsis 22 22
Urinary Tract Infection 22 22
Inflammation 13 13
No Information 7 7
Foreign Body In Patient 7 7
Injury 5 5
Electric Shock 5 5
Hematuria 5 5
Burn(s) 5 5
Fever 4 4
Urinary Retention 4 4
Patient Problem/Medical Problem 4 4
Device Embedded In Tissue or Plaque 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Insufficient Information 2 2
Blood Loss 2 2
Laceration(s) 2 2
Pain 1 1
Perforation 1 1
Local Reaction 1 1
Shock 1 1
Skin Discoloration 1 1
Swelling 1 1
Tissue Damage 1 1
Hearing Loss 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Death 1 1
Irritation 1 1
Syncope 1 1
Numbness 1 1
Burn, Thermal 1 1
No Code Available 1 1
Unspecified Tissue Injury 1 1
Full thickness (Third Degree) Burn 1 1
No Clinical Signs, Symptoms or Conditions 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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