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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
  1.  K160766  Ambu USR, Ambu M
  2.  K193095  Ambu aScope 4 Cysto
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
2015 28 28
2016 75 75
2017 79 79
2018 79 79
2019 101 101
2020 242 242

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 168 168
Adverse Event Without Identified Device or Use Problem 111 111
Break 53 53
No Display/Image 46 46
Contamination /Decontamination Problem 30 30
Endoscope 29 29
Device Reprocessing Problem 28 28
Insufficient Information 24 24
Poor Quality Image 19 19
Detachment of Device or Device Component 12 12
Fluid Leak 11 11
Appropriate Term/Code Not Available 11 11
Erratic or Intermittent Display 11 11
Tip 8 8
Output Problem 7 7
Defective Device 7 7
Electrical /Electronic Property Problem 7 7
Material Integrity Problem 7 7
Device Contamination with Chemical or Other Material 6 6
Detachment Of Device Component 6 6
Failure to Power Up 6 6
Electrode 5 5
Material Fragmentation 5 5
Material Split, Cut or Torn 5 5
Loose or Intermittent Connection 5 5
Peeled/Delaminated 4 4
Material Disintegration 4 4
Display or Visual Feedback Problem 4 4
Difficult to Remove 4 4
Fracture 4 4
Problem with Sterilization 4 4
Material Separation 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
Electrical Power Problem 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
Crack 2 2
Degraded 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
Overheating of Device 1 1
Particulates 1 1
Cord 1 1
Cap 1 1
Complete Blockage 1 1
Collapse 1 1
Component Missing 1 1
Split 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 Protrusion/Extrusion 1 1
Material Twisted/Bent 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
Fail-Safe Problem 1 1
Device Unsafe to Use in Environment 1 1
Device Contamination With Biological Material 1 1
Scratched 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 125 125
No Patient Involvement 82 82
Bacterial Infection 52 52
Sepsis 21 21
Urinary Tract Infection 18 18
Inflammation 13 13
Foreign Body In Patient 9 9
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
Patient Problem/Medical Problem 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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