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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 2
KARL STORZ SE & CO KG
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 28 28
2016 75 75
2017 79 79
2018 79 79
2019 101 101
2020 187 187

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 162 162
Adverse Event Without Identified Device or Use Problem 105 105
Break 52 52
No Display/Image 39 39
Endoscope 29 29
Device Reprocessing Problem 24 24
Insufficient Information 24 24
Contamination /Decontamination Problem 21 21
Poor Quality Image 15 15
Detachment of Device or Device Component 12 12
Appropriate Term/Code Not Available 11 11
Fluid Leak 10 10
Tip 8 8
Erratic or Intermittent Display 8 8
Material Integrity Problem 7 7
Device Contamination with Chemical or Other Material 6 6
Detachment Of Device Component 6 6
Output Problem 6 6
Material Split, Cut or Torn 5 5
Electrode 5 5
Material Fragmentation 5 5
Electrical /Electronic Property Problem 5 5
Peeled/Delaminated 4 4
Loose or Intermittent Connection 4 4
Fracture 4 4
Difficult to Remove 4 4
Problem with Sterilization 4 4
Material Disintegration 3 3
Failure to Power Up 3 3
Defective Device 3 3
No Apparent Adverse Event 3 3
Material Deformation 3 3
Device Fell 3 3
Power Problem 2 2
Leak/Splash 2 2
Connection Problem 2 2
Device Disinfection Or Sterilization Issue 2 2
Entrapment of Device 2 2
Corroded 2 2
Device Dislodged or Dislocated 2 2
Use of Device Problem 2 2
Material Perforation 2 2
Material Separation 2 2
Hole In Material 2 2
Labelling, Instructions for Use or Training Problem 2 2
Mechanical Problem 2 2
No Device Output 2 2
Display or Visual Feedback Problem 2 2
Crack 2 2
Degraded 2 2
Overheating of Device 1 1
Cord 1 1
Cap 1 1
Complete Blockage 1 1
Collapse 1 1
Folded 1 1
Deformation Due to Compressive Stress 1 1
Activation, Positioning or SeparationProblem 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Material Twisted/Bent 1 1
Component Missing 1 1
Split 1 1
Packaging Problem 1 1
Temperature Problem 1 1
Knife 1 1
Unclear Information 1 1
Device Handling Problem 1 1
Material Discolored 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
Failure to Fold 1 1
Image Display Error/Artifact 1 1
Product Quality Problem 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Device Unsafe to Use in Environment 1 1
Electrical Power Problem 1 1
Fail-Safe Problem 1 1
Device Contamination With Biological Material 1 1
Cannula 1 1
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Clean Adequately 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 144 144
Unspecified Infection 128 128
No Consequences Or Impact To Patient 91 91
No Patient Involvement 67 67
Bacterial Infection 52 52
Sepsis 21 21
Urinary Tract Infection 18 18
Foreign Body In Patient 9 9
Inflammation 8 8
No Information 7 7
Electric Shock 5 5
Injury 5 5
Burn(s) 5 5
Fever 4 4
Device Embedded In Tissue or Plaque 4 4
Blood Loss 2 2
Laceration(s) 2 2
Pain 1 1
Local Reaction 1 1
Shock 1 1
Tissue Damage 1 1
Burn, Thermal 1 1
Death 1 1
Hemorrhage/Bleeding 1 1
Full thickness (Third Degree) Burn 1 1
Syncope 1 1
No Code Available 1 1
Hearing Loss 1 1
Hypersensitivity/Allergic reaction 1 1
Irritation 1 1
Perforation 1 1
Skin Discoloration 1 1
Swelling 1 1
Numbness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
2 Customed, Inc II Sep-03-2015
3 Medivators, Inc. II Apr-23-2020
4 Pentax Medical Company II Jun-28-2016
5 Pentax of America Inc II Feb-14-2018
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