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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
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
BYRNE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CANADA ENDOSCOPE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EMMY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HENKE-SASS, WOLF GMBH
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  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
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
  SUBSTANTIALLY EQUIVALENT 1
MEDIVATORS INC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLACE THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UROVIU CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
UVISION360 INC.
  SUBSTANTIALLY EQUIVALENT 1
UVISION360, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 6 6
2015 28 28
2016 75 75
2017 79 79
2018 79 79
2019 102 102
2020 339 339
2021 494 494
2022 744 744
2023 920 920
2024 336 336

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 404 404
Break 335 335
No Display/Image 297 297
Device Reprocessing Problem 284 284
Failure to Clean Adequately 246 246
Fluid/Blood Leak 169 169
Adverse Event Without Identified Device or Use Problem 167 167
Detachment of Device or Device Component 129 129
Erratic or Intermittent Display 103 103
Contamination 75 75
Loose or Intermittent Connection 75 75
Failure to Power Up 73 73
Contamination /Decontamination Problem 71 71
Insufficient Information 69 69
Electrical /Electronic Property Problem 68 68
Poor Quality Image 66 66
Material Split, Cut or Torn 58 58
Peeled/Delaminated 47 47
Mechanical Problem 38 38
Material Separation 31 31
Leak/Splash 30 30
Material Deformation 29 29
Display or Visual Feedback Problem 27 27
Power Problem 25 25
Optical Obstruction 23 23
Grounding Malfunction 23 23
Crack 23 23
Scratched Material 22 22
Connection Problem 21 21
Component Missing 20 20
Unintended Movement 20 20
No Device Output 20 20
Output Problem 19 19
Material Protrusion/Extrusion 19 19
Improper or Incorrect Procedure or Method 18 18
Defective Component 17 17
Material Integrity Problem 16 16
Material Discolored 16 16
Defective Device 15 15
Device Contamination with Chemical or Other Material 14 14
Material Twisted/Bent 14 14
Material Fragmentation 14 14
Image Display Error/Artifact 14 14
Optical Problem 12 12
No Visual Prompts/Feedback 12 12
Appropriate Term/Code Not Available 11 11
Corroded 11 11
Degraded 9 9
Material Rupture 9 9
Deformation Due to Compressive Stress 9 9
Optical Distortion 9 9
Obstruction of Flow 9 9
Key or Button Unresponsive/not Working 9 9
Unexpected Shutdown 8 8
Difficult to Remove 8 8
Fracture 8 8
Thermal Decomposition of Device 7 7
Use of Device Problem 7 7
Mechanical Jam 7 7
Communication or Transmission Problem 6 6
Device Dislodged or Dislocated 6 6
Loss of Power 6 6
Detachment Of Device Component 6 6
Material Disintegration 5 5
Electrical Power Problem 5 5
Temperature Problem 5 5
No Apparent Adverse Event 5 5
Device Fell 5 5
Device Handling Problem 5 5
Physical Resistance/Sticking 5 5
Material Perforation 4 4
Problem with Sterilization 4 4
Device Difficult to Setup or Prepare 4 4
Separation Problem 4 4
Material Puncture/Hole 3 3
Product Quality Problem 3 3
Unraveled Material 3 3
Pitted 3 3
Overheating of Device 3 3
Labelling, Instructions for Use or Training Problem 3 3
Circuit Failure 3 3
Excessive Heating 3 3
Device Operates Differently Than Expected 3 3
Arcing 3 3
Sparking 2 2
Structural Problem 2 2
Failure to Advance 2 2
Device Damaged by Another Device 2 2
Electrical Shorting 2 2
Device Disinfection Or Sterilization Issue 2 2
Complete Loss of Power 2 2
Intermittent Loss of Power 2 2
Noise, Audible 2 2
Calcified 2 2
Complete Blockage 2 2
Collapse 2 2
Accessory Incompatible 2 2
Disconnection 2 2
Failure to Disinfect 2 2
Entrapment of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2060 2060
No Consequences Or Impact To Patient 247 247
Urinary Tract Infection 226 226
Unspecified Infection 186 186
No Known Impact Or Consequence To Patient 144 144
No Patient Involvement 136 136
Bacterial Infection 95 95
Sepsis 71 71
Fever 64 64
Insufficient Information 49 49
Pain 30 30
Foreign Body In Patient 24 24
Inflammation 17 17
Urinary Frequency 14 14
Chills 11 11
No Information 9 9
Nausea 8 8
Hemorrhage/Bleeding 7 7
Burn(s) 6 6
Hematuria 6 6
Injury 5 5
Electric Shock 5 5
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Dysuria 4 4
Patient Problem/Medical Problem 4 4
Urinary Retention 4 4
Laceration(s) 4 4
Pneumothorax 3 3
Burning Sensation 3 3
Hemoptysis 3 3
Hypersensitivity/Allergic reaction 3 3
Perforation 3 3
Viral Infection 3 3
Drug Resistant Bacterial Infection 3 3
Unspecified Tissue Injury 3 3
Unspecified Kidney or Urinary Problem 2 2
Respiratory Failure 2 2
Blood Loss 2 2
Pneumonia 2 2
Local Reaction 1 1
Renal Failure 1 1
Shock 1 1
Skin Discoloration 1 1
Swelling 1 1
Tissue Damage 1 1
Discomfort 1 1
Rupture 1 1
Pleural Effusion 1 1
Internal Organ Perforation 1 1
Irritation 1 1
Syncope 1 1
Hearing Loss 1 1
Hematoma 1 1
Cardiac Arrest 1 1
Death 1 1
Dyspnea 1 1
Pseudoaneurysm 1 1
Full thickness (Third Degree) Burn 1 1
Burn, Thermal 1 1
Malaise 1 1
Numbness 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
No Code Available 1 1
Renal Impairment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Customed, Inc II Apr-14-2016
3 Customed, Inc II Sep-03-2015
4 Karl Storz Endoscopy II Jun-03-2022
5 Karl Storz Endoscopy II May-12-2022
6 Medivators, Inc. II Apr-23-2020
7 Olympus Corporation of the Americas II Jun-13-2022
8 Pentax Medical Company II Jun-28-2016
9 Pentax of America Inc II Feb-14-2018
10 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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