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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 2
UVISION360, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 331 331
Break 307 307
No Display/Image 293 293
Device Reprocessing Problem 276 276
Failure to Clean Adequately 246 246
Fluid/Blood Leak 168 168
Detachment of Device or Device Component 125 125
Erratic or Intermittent Display 103 103
Adverse Event Without Identified Device or Use Problem 102 102
Contamination 75 75
Loose or Intermittent Connection 73 73
Failure to Power Up 73 73
Electrical /Electronic Property Problem 68 68
Poor Quality Image 66 66
Material Split, Cut or Torn 58 58
Contamination /Decontamination Problem 52 52
Peeled/Delaminated 46 46
Insufficient Information 45 45
Mechanical Problem 38 38
Material Separation 31 31
Leak/Splash 30 30
Material Deformation 28 28
Display or Visual Feedback Problem 27 27
Power Problem 25 25
Optical Obstruction 23 23
Grounding Malfunction 23 23
Scratched Material 22 22
Crack 21 21
Component Missing 20 20
Connection Problem 20 20
Unintended Movement 20 20
Output Problem 19 19
Material Protrusion/Extrusion 19 19
Improper or Incorrect Procedure or Method 18 18
No Device Output 18 18
Defective Component 17 17
Material Discolored 16 16
Defective Device 15 15
Material Integrity Problem 15 15
Material Twisted/Bent 14 14
Image Display Error/Artifact 14 14
Optical Problem 12 12
No Visual Prompts/Feedback 12 12
Material Fragmentation 10 10
Corroded 10 10
Material Rupture 9 9
Obstruction of Flow 9 9
Key or Button Unresponsive/not Working 9 9
Device Contamination with Chemical or Other Material 9 9
Optical Distortion 9 9
Deformation Due to Compressive Stress 8 8
Unexpected Shutdown 8 8
Mechanical Jam 7 7
Degraded 7 7
Thermal Decomposition of Device 7 7
Fracture 6 6
Use of Device Problem 6 6
Difficult to Remove 6 6
Loss of Power 6 6
Communication or Transmission Problem 6 6
Device Dislodged or Dislocated 5 5
Electrical Power Problem 5 5
Device Fell 5 5
Physical Resistance/Sticking 5 5
Device Handling Problem 4 4
Separation Problem 4 4
Temperature Problem 4 4
Device Difficult to Setup or Prepare 4 4
Problem with Sterilization 4 4
Material Perforation 4 4
Unraveled Material 3 3
Material Puncture/Hole 3 3
Pitted 3 3
Overheating of Device 3 3
Labelling, Instructions for Use or Training Problem 3 3
Material Disintegration 3 3
Circuit Failure 3 3
Arcing 3 3
Excessive Heating 3 3
Complete Loss of Power 2 2
Intermittent Loss of Power 2 2
Noise, Audible 2 2
No Apparent Adverse Event 2 2
Device Contaminated at the User Facility 2 2
Sparking 2 2
Electrical Shorting 2 2
Device Damaged by Another Device 2 2
Calcified 2 2
Complete Blockage 2 2
Accessory Incompatible 2 2
Disconnection 2 2
Failure to Disinfect 2 2
Difficult to Insert 2 2
Flaked 2 2
Product Quality Problem 2 2
Device Damaged Prior to Use 2 2
Structural Problem 2 2
Failure to Advance 2 2
Dent in Material 1 1
Separation Failure 1 1

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 231 231
Urinary Tract Infection 217 217
No Patient Involvement 133 133
Unspecified Infection 104 104
Sepsis 65 65
Fever 63 63
Bacterial Infection 61 61
No Known Impact Or Consequence To Patient 54 54
Insufficient Information 49 49
Pain 30 30
Foreign Body In Patient 16 16
Inflammation 15 15
Urinary Frequency 14 14
Chills 11 11
Nausea 8 8
Hemorrhage/Bleeding 7 7
Hematuria 6 6
Electric Shock 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Burn(s) 5 5
Urinary Retention 4 4
Patient Problem/Medical Problem 4 4
Injury 3 3
Drug Resistant Bacterial Infection 3 3
Unspecified Tissue Injury 3 3
Pneumothorax 3 3
Viral Infection 3 3
Burning Sensation 3 3
Hemoptysis 3 3
Hypersensitivity/Allergic reaction 3 3
Laceration(s) 2 2
Perforation 2 2
Pneumonia 2 2
Unspecified Kidney or Urinary Problem 2 2
Respiratory Failure 2 2
Dysuria 2 2
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
No Code Available 1 1
Renal Impairment 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Malaise 1 1
Numbness 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 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
Discomfort 1 1
Pleural Effusion 1 1
Internal Organ Perforation 1 1
Syncope 1 1
Hematoma 1 1
Cardiac Arrest 1 1
Death 1 1
Dyspnea 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 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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