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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
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 452 452

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 379 379
Device Reprocessing Problem 330 330
Break 311 311
No Display/Image 304 304
Failure to Clean Adequately 274 274
Fluid/Blood Leak 174 174
Detachment of Device or Device Component 136 136
Erratic or Intermittent Display 104 104
Adverse Event Without Identified Device or Use Problem 102 102
Failure to Power Up 78 78
Loose or Intermittent Connection 77 77
Contamination 75 75
Electrical /Electronic Property Problem 68 68
Poor Quality Image 67 67
Material Split, Cut or Torn 62 62
Contamination /Decontamination Problem 52 52
Peeled/Delaminated 47 47
Insufficient Information 45 45
Mechanical Problem 39 39
Material Separation 32 32
Leak/Splash 31 31
Material Deformation 30 30
Display or Visual Feedback Problem 29 29
Power Problem 25 25
Optical Obstruction 24 24
Grounding Malfunction 23 23
Scratched Material 22 22
Crack 21 21
Component Missing 21 21
No Device Output 20 20
Unintended Movement 20 20
Material Protrusion/Extrusion 20 20
Connection Problem 20 20
Output Problem 19 19
Improper or Incorrect Procedure or Method 18 18
Defective Component 17 17
Material Discolored 16 16
Material Integrity Problem 16 16
Defective Device 15 15
Material Twisted/Bent 14 14
Optical Problem 14 14
Image Display Error/Artifact 14 14
Material Fragmentation 12 12
No Visual Prompts/Feedback 12 12
Corroded 10 10
Obstruction of Flow 10 10
Material Rupture 9 9
Key or Button Unresponsive/not Working 9 9
Device Contamination with Chemical or Other Material 9 9
Optical Distortion 9 9
Mechanical Jam 8 8
Deformation Due to Compressive Stress 8 8
Unexpected Shutdown 8 8
Flaked 7 7
Degraded 7 7
Thermal Decomposition of Device 7 7
Fracture 6 6
Difficult to Remove 6 6
Use of Device Problem 6 6
Loss of Power 6 6
Communication or Transmission Problem 6 6
Device Dislodged or Dislocated 5 5
Electrical Power Problem 5 5
Physical Resistance/Sticking 5 5
Device Fell 5 5
Temperature Problem 4 4
Device Handling Problem 4 4
Separation Problem 4 4
Device Difficult to Setup or Prepare 4 4
Material Perforation 4 4
Problem with Sterilization 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
Excessive Heating 3 3
Arcing 3 3
Sparking 2 2
Electrical Shorting 2 2
Device Damaged by Another Device 2 2
No Apparent Adverse Event 2 2
Complete Loss of Power 2 2
Intermittent Loss of Power 2 2
Sharp Edges 2 2
Noise, Audible 2 2
Device Contaminated at the User Facility 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
Product Quality Problem 2 2
Smoking 2 2
Material Too Rigid or Stiff 2 2
Device Damaged Prior to Use 2 2
Structural Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2170 2170
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 51 51
Pain 30 30
Foreign Body In Patient 20 20
Inflammation 15 15
Urinary Frequency 14 14
Chills 11 11
Hemorrhage/Bleeding 9 9
Nausea 8 8
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
Unspecified Kidney or Urinary Problem 4 4
Patient Problem/Medical Problem 4 4
Respiratory Failure 4 4
Rupture 3 3
Viral Infection 3 3
Injury 3 3
Drug Resistant Bacterial Infection 3 3
Unspecified Tissue Injury 3 3
Burning Sensation 3 3
Hemoptysis 3 3
Pneumothorax 3 3
Cardiac Arrest 3 3
Hypersensitivity/Allergic reaction 3 3
Hypoxia 2 2
Ischemia 2 2
Laceration(s) 2 2
Aneurysm 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Pneumonia 2 2
Necrosis 2 2
Perforation 2 2
Septic Shock 2 2
Thrombosis/Thrombus 2 2
Increased Intra-Peritoneal Volume (IIPV) 2 2
Vascular Dissection 2 2
Dysuria 2 2
Ascites 2 2
Blood Loss 1 1
Pseudoaneurysm 1 1
Malaise 1 1
Numbness 1 1
Needle Stick/Puncture 1 1
Low Oxygen Saturation 1 1
Discomfort 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
No Code Available 1 1
Full thickness (Third Degree) Burn 1 1
Renal Impairment 1 1
Shock 1 1
Skin Discoloration 1 1
Swelling 1 1
Tissue Damage 1 1
Pleural Effusion 1 1
Internal Organ Perforation 1 1
Local Reaction 1 1
Renal Failure 1 1
Dyspnea 1 1
Syncope 1 1
Death 1 1
Hematoma 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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