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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 3
AMERICAN MEDICAL ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 2
COGENTIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  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 2
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRAUSS SURGICAL USA
  SUBSTANTIALLY EQUIVALENT 1
UROVIU CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
UVISION360, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZENFLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 494 494
2022 744 744
2023 920 929
2024 892 892
2025 2700 2701
2026 2080 2080

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 2165 2166
Failure to Clean Adequately 813 813
Device Reprocessing Problem 640 641
Break 513 513
Corroded 462 462
Loss of or Failure to Bond 404 404
Microbial Contamination of Device 370 370
No Display/Image 339 339
Material Separation 240 240
Peeled/Delaminated 222 222
Material Split, Cut or Torn 197 197
Fluid/Blood Leak 192 192
Poor Quality Image 169 169
Degraded 167 167
Material Deformation 165 165
Contamination 146 146
Erratic or Intermittent Display 119 119
Loose or Intermittent Connection 113 113
Failure to Power Up 84 84
Contamination /Decontamination Problem 78 78
Optical Problem 76 76
Crack 75 75
Adverse Event Without Identified Device or Use Problem 69 69
Optical Obstruction 68 68
Leak/Splash 66 72
Component Missing 60 60
Electrical /Electronic Property Problem 60 60
Material Integrity Problem 55 55
Insufficient Information 53 54
Material Fragmentation 49 49
Mechanical Problem 48 48
Scratched Material 47 47
Gas/Air Leak 44 44
Residue After Decontamination 42 42
Material Protrusion/Extrusion 40 40
Display or Visual Feedback Problem 38 38
Material Discolored 37 37
Unstable 35 35
Dent in Material 32 32
Obstruction of Flow 31 31
Optical Distortion 31 31
No Device Output 29 29
Environmental Particulates 27 27
Chemical Problem 26 26
Power Problem 24 24
Unintended Movement 24 24
Grounding Malfunction 23 23
Mechanical Jam 23 23
Material Puncture/Hole 22 22
Improper or Incorrect Procedure or Method 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7231 7240
Urinary Tract Infection 249 249
Insufficient Information 123 123
Unspecified Infection 81 81
Fever 69 69
No Consequences Or Impact To Patient 66 66
Sepsis 61 61
Bacterial Infection 46 46
Dysuria 34 34
Pain 32 32
No Patient Involvement 29 29
Urinary Frequency 22 22
Foreign Body In Patient 20 20
Hematuria 13 13
Chills 11 11
Hemorrhage/Bleeding 10 10
Nausea 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Unspecified Kidney or Urinary Problem 4 4
Inflammation 4 4
Urinary Retention 4 4
Low Blood Pressure/ Hypotension 3 3
Viral Infection 3 3
Burning Sensation 3 3
Burn(s) 3 4
Hemoptysis 3 3
Drug Resistant Bacterial Infection 3 3
Pneumothorax 3 3
Fall 2 2
Pneumonia 2 2
Unspecified Tissue Injury 2 2
Fatigue 2 2
Hypersensitivity/Allergic reaction 2 2
Respiratory Failure 2 2
Abdominal Pain 2 2
Cardiac Arrest 1 1
Needle Stick/Puncture 1 1
Rupture 1 1
Anemia 1 1
Malaise 1 1
Perforation 1 1
Chest Pain 1 1
Pleural Effusion 1 1
Discomfort 1 1
Hematoma 1 1
Dyspnea 1 1
Laceration(s) 1 1
Renal Impairment 1 1
Renal Failure 1 1
Pseudoaneurysm 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 Olympus Corporation of the Americas II Jun-13-2022
5 Shirakawa Olympus Co., Ltd. II Jan-09-2024
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