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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
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 4
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 921 921
2024 895 895
2025 525 525

Device Problems MDRs with this Device Problem Events in those MDRs
Device Reprocessing Problem 437 437
Failure to Clean Adequately 427 427
Microbial Contamination of Device 372 372
Break 368 368
No Display/Image 365 365
Detachment of Device or Device Component 247 247
Fluid/Blood Leak 199 199
Erratic or Intermittent Display 127 127
Loose or Intermittent Connection 102 102
Poor Quality Image 102 102
Contamination 100 100
Failure to Power Up 92 92
Material Split, Cut or Torn 84 84
Adverse Event Without Identified Device or Use Problem 74 74
Electrical /Electronic Property Problem 69 69
Peeled/Delaminated 68 68
Material Separation 56 56
Material Deformation 54 54
Contamination /Decontamination Problem 53 53
Optical Obstruction 53 53
Leak/Splash 51 51
Optical Problem 50 50
Insufficient Information 48 48
Mechanical Problem 39 39
Display or Visual Feedback Problem 31 31
Power Problem 27 27
Component Missing 26 26
Crack 26 26
No Device Output 26 26
Scratched Material 26 26
Material Integrity Problem 26 26
Output Problem 24 24
Grounding Malfunction 23 23
Material Protrusion/Extrusion 23 23
Unintended Movement 22 22
Degraded 22 22
Connection Problem 21 21
Improper or Incorrect Procedure or Method 20 20
Obstruction of Flow 17 17
Defective Component 17 17
Optical Distortion 17 17
No Visual Prompts/Feedback 16 16
Image Display Error/Artifact 16 16
Material Twisted/Bent 16 16
Defective Device 16 16
Material Discolored 15 15
Use of Device Problem 14 14
Material Rupture 14 14
Material Fragmentation 14 14
Corroded 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3063 3063
Urinary Tract Infection 229 229
No Consequences Or Impact To Patient 225 225
No Patient Involvement 133 133
Unspecified Infection 99 99
Insufficient Information 96 96
Fever 68 68
Bacterial Infection 55 55
Sepsis 52 52
Pain 29 29
Foreign Body In Patient 21 21
Urinary Frequency 14 14
No Known Impact Or Consequence To Patient 13 13
Dysuria 12 12
Chills 11 11
Hemorrhage/Bleeding 10 10
Inflammation 9 9
Nausea 8 8
Hematuria 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Burn(s) 7 7
Patient Problem/Medical Problem 4 4
Respiratory Failure 4 4
Electric Shock 4 4
Unspecified Kidney or Urinary Problem 4 4
Urinary Retention 4 4
Drug Resistant Bacterial Infection 3 3
Pneumothorax 3 3
Unspecified Tissue Injury 3 3
Viral Infection 3 3
Burning Sensation 3 3
Cardiac Arrest 3 3
Rupture 3 3
Hemoptysis 3 3
Thrombosis/Thrombus 2 2
Necrosis 2 2
Vascular Dissection 2 2
Septic Shock 2 2
Increased Intra-Peritoneal Volume (IIPV) 2 2
Hypersensitivity/Allergic reaction 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Pneumonia 2 2
Aneurysm 2 2
Hypoxia 2 2
Ischemia 2 2
Perforation 2 2
Ascites 2 2
Needle Stick/Puncture 1 1
No Information 1 1
Pleural Effusion 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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