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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 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
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  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
2018 79 79
2019 102 102
2020 339 339
2021 494 494
2022 744 744
2023 661 661

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 307 307
Break 282 282
No Display/Image 264 264
Device Reprocessing Problem 209 209
Fluid/Blood Leak 140 140
Detachment of Device or Device Component 103 103
Adverse Event Without Identified Device or Use Problem 100 100
Failure to Clean Adequately 98 98
Erratic or Intermittent Display 92 92
Electrical /Electronic Property Problem 66 66
Poor Quality Image 64 64
Failure to Power Up 62 62
Contamination /Decontamination Problem 58 58
Loose or Intermittent Connection 53 53
Material Split, Cut or Torn 46 46
Contamination 45 45
Mechanical Problem 35 35
Peeled/Delaminated 34 34
Material Separation 26 26
Display or Visual Feedback Problem 25 25
Power Problem 24 24
Material Deformation 23 23
Grounding Malfunction 23 23
Scratched Material 22 22
Crack 19 19
Component Missing 18 18
Unintended Movement 18 18
Connection Problem 18 18
Optical Obstruction 17 17
Improper or Incorrect Procedure or Method 17 17
Material Discolored 16 16
Output Problem 16 16
Material Protrusion/Extrusion 16 16
Material Integrity Problem 15 15
Defective Device 15 15
Defective Component 14 14
Image Display Error/Artifact 14 14
Material Twisted/Bent 14 14
No Device Output 13 13
Leak/Splash 11 11
Optical Problem 11 11
Device Contamination with Chemical or Other Material 10 10
Material Fragmentation 10 10
Corroded 9 9
Obstruction of Flow 9 9
Key or Button Unresponsive/not Working 9 9
Appropriate Term/Code Not Available 8 8
Deformation Due to Compressive Stress 8 8
Material Rupture 8 8
Difficult to Remove 7 7
Optical Distortion 7 7
Mechanical Jam 7 7
No Visual Prompts/Feedback 6 6
Loss of Power 6 6
Fracture 6 6
Degraded 6 6
Unexpected Shutdown 5 5
Device Fell 5 5
Temperature Problem 5 5
Electrical Power Problem 5 5
Communication or Transmission Problem 5 5
Device Dislodged or Dislocated 4 4
Physical Resistance/Sticking 4 4
Device Handling Problem 4 4
No Apparent Adverse Event 4 4
Separation Problem 4 4
Device Difficult to Setup or Prepare 4 4
Problem with Sterilization 4 4
Unraveled Material 3 3
Use of Device Problem 3 3
Material Perforation 3 3
Arcing 3 3
Material Puncture/Hole 3 3
Overheating of Device 3 3
Circuit Failure 3 3
Labelling, Instructions for Use or Training Problem 3 3
Material Disintegration 3 3
Excessive Heating 3 3
Insufficient Information 3 3
Noise, Audible 2 2
Complete Loss of Power 2 2
Intermittent Loss of Power 2 2
Device Contaminated at the User Facility 2 2
Device Damaged by Another Device 2 2
Failure to Disinfect 2 2
Flaked 2 2
Calcified 2 2
Complete Blockage 2 2
Product Quality Problem 2 2
Sparking 2 2
Structural Problem 2 2
Failure to Advance 2 2
Separation Failure 1 1
Blocked Connection 1 1
Device Damaged Prior to Use 1 1
Failure to Read Input Signal 1 1
Smoking 1 1
Material Too Rigid or Stiff 1 1
Particulates 1 1
Misconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1638 1638
No Consequences Or Impact To Patient 235 235
No Patient Involvement 133 133
No Known Impact Or Consequence To Patient 102 102
Urinary Tract Infection 97 97
Unspecified Infection 93 93
Bacterial Infection 54 54
Fever 43 43
Insufficient Information 43 43
Pain 29 29
Sepsis 18 18
Inflammation 17 17
Foreign Body In Patient 14 14
Urinary Frequency 14 14
Chills 11 11
Nausea 8 8
Hemorrhage/Bleeding 7 7
Hematuria 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Electric Shock 5 5
Burn(s) 5 5
Urinary Retention 4 4
Injury 4 4
Patient Problem/Medical Problem 4 4
Unspecified Tissue Injury 3 3
Viral Infection 3 3
Pneumothorax 3 3
Hemoptysis 3 3
Laceration(s) 2 2
Pneumonia 2 2
Unspecified Kidney or Urinary Problem 2 2
Drug Resistant Bacterial Infection 2 2
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Dysuria 2 2
Respiratory Failure 2 2
Burn, Thermal 1 1
Discomfort 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
No Code Available 1 1
Renal Impairment 1 1
Full thickness (Third Degree) Burn 1 1
Perforation 1 1
Pleural Effusion 1 1
Hypersensitivity/Allergic reaction 1 1
Syncope 1 1
Hematoma 1 1
Cardiac Arrest 1 1
Death 1 1
Dyspnea 1 1
Local Reaction 1 1
Renal Failure 1 1
Shock 1 1
Skin Discoloration 1 1
Swelling 1 1
Tissue Damage 1 1
Rupture 1 1
Malaise 1 1
Numbness 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Karl Storz Endoscopy II Jun-03-2022
3 Karl Storz Endoscopy II May-12-2022
4 Medivators, Inc. II Apr-23-2020
5 Olympus Corporation of the Americas II Jun-13-2022
6 Pentax of America Inc II Feb-14-2018
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