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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
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 3
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO. LTD
  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
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
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
2020 339 339
2021 494 494
2022 744 744
2023 920 920
2024 896 896
2025 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Device Reprocessing Problem 387 387
Failure to Clean Adequately 375 375
Microbial Contamination of Device 364 364
No Display/Image 343 343
Break 337 337
Fluid/Blood Leak 197 197
Detachment of Device or Device Component 180 180
Erratic or Intermittent Display 119 119
Loose or Intermittent Connection 93 93
Contamination 88 88
Failure to Power Up 87 87
Poor Quality Image 78 78
Adverse Event Without Identified Device or Use Problem 74 74
Material Split, Cut or Torn 72 72
Electrical /Electronic Property Problem 69 69
Peeled/Delaminated 55 55
Contamination /Decontamination Problem 52 52
Leak/Splash 47 47
Insufficient Information 45 45
Optical Obstruction 42 42
Material Separation 39 39
Mechanical Problem 38 38
Material Deformation 36 36
Display or Visual Feedback Problem 31 31
Power Problem 27 27
No Device Output 26 26
Scratched Material 24 24
Component Missing 23 23
Grounding Malfunction 23 23
Crack 22 22
Material Protrusion/Extrusion 21 21
Connection Problem 21 21
Unintended Movement 21 21
Output Problem 21 21
Optical Problem 20 20
Improper or Incorrect Procedure or Method 19 19
Defective Component 17 17
Obstruction of Flow 16 16
Image Display Error/Artifact 16 16
Defective Device 16 16
Material Twisted/Bent 15 15
Material Discolored 15 15
No Visual Prompts/Feedback 15 15
Material Fragmentation 13 13
Material Rupture 11 11
Material Integrity Problem 11 11
Degraded 11 11
Corroded 10 10
Optical Distortion 10 10
Key or Button Unresponsive/not Working 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2630 2630
Urinary Tract Infection 229 229
No Consequences Or Impact To Patient 225 225
No Patient Involvement 133 133
Unspecified Infection 97 97
Fever 68 68
Insufficient Information 64 64
Bacterial Infection 55 55
Sepsis 51 51
Pain 29 29
Foreign Body In Patient 21 21
Urinary Frequency 14 14
No Known Impact Or Consequence To Patient 13 13
Chills 11 11
Dysuria 10 10
Inflammation 9 9
Hematuria 8 8
Hemorrhage/Bleeding 8 8
Nausea 8 8
Burn(s) 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Unspecified Kidney or Urinary Problem 4 4
Electric Shock 4 4
Respiratory Failure 4 4
Patient Problem/Medical Problem 4 4
Urinary Retention 4 4
Rupture 3 3
Viral Infection 3 3
Drug Resistant Bacterial Infection 3 3
Unspecified Tissue Injury 3 3
Burning Sensation 3 3
Hemoptysis 3 3
Cardiac Arrest 3 3
Pneumothorax 3 3
Septic Shock 2 2
Aneurysm 2 2
Hypoxia 2 2
Pneumonia 2 2
Thrombosis/Thrombus 2 2
Ischemia 2 2
Necrosis 2 2
Ascites 2 2
Hypersensitivity/Allergic reaction 2 2
Increased Intra-Peritoneal Volume (IIPV) 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Perforation 2 2
Vascular Dissection 2 2
Respiratory Insufficiency 1 1
Chest Pain 1 1
Low Oxygen Saturation 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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