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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
AMERICAN MEDICAL ENDOSCOPY, INC. (DBA STRAUSS SURGICAL)
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
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 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  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
2020 339 339
2021 494 494
2022 744 744
2023 920 921
2024 892 892
2025 2037 2038

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 968 969
Failure to Clean Adequately 573 573
Device Reprocessing Problem 516 516
Break 452 452
No Display/Image 388 388
Microbial Contamination of Device 387 387
Fluid/Blood Leak 202 202
Material Split, Cut or Torn 149 149
Peeled/Delaminated 141 141
Poor Quality Image 141 141
Corroded 136 136
Erratic or Intermittent Display 132 132
Contamination 120 120
Material Separation 115 115
Loose or Intermittent Connection 110 110
Material Deformation 106 106
Failure to Power Up 94 94
Loss of or Failure to Bond 87 87
Adverse Event Without Identified Device or Use Problem 86 86
Electrical /Electronic Property Problem 72 72
Optical Problem 66 66
Degraded 63 63
Contamination /Decontamination Problem 59 59
Optical Obstruction 58 58
Leak/Splash 56 56
Insufficient Information 51 51
Crack 49 49
Material Integrity Problem 45 45
Mechanical Problem 45 45
Component Missing 44 44
Scratched Material 40 40
Gas/Air Leak 35 35
Display or Visual Feedback Problem 34 34
Material Protrusion/Extrusion 32 32
Power Problem 29 29
No Device Output 27 27
Output Problem 26 26
Improper or Incorrect Procedure or Method 26 26
Unintended Movement 24 24
Obstruction of Flow 24 24
Grounding Malfunction 23 23
Optical Distortion 23 23
Connection Problem 22 22
Material Fragmentation 22 22
Material Discolored 20 20
Defective Component 18 18
Material Rupture 17 17
Physical Resistance/Sticking 17 17
Deformation Due to Compressive Stress 17 17
Residue After Decontamination 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4540 4542
Urinary Tract Infection 249 249
No Consequences Or Impact To Patient 225 225
No Patient Involvement 133 133
Insufficient Information 105 105
Unspecified Infection 103 103
Fever 70 70
Sepsis 58 58
Bacterial Infection 57 57
Pain 31 31
Foreign Body In Patient 21 21
Urinary Frequency 16 16
Dysuria 16 16
No Known Impact Or Consequence To Patient 13 13
Chills 11 11
Hematuria 10 10
Inflammation 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Nausea 8 8
Hemorrhage/Bleeding 8 8
Burn(s) 7 7
Patient Problem/Medical Problem 4 4
Electric Shock 4 4
Unspecified Kidney or Urinary Problem 4 4
Urinary Retention 4 4
Low Blood Pressure/ Hypotension 3 3
Unspecified Tissue Injury 3 3
Viral Infection 3 3
Burning Sensation 3 3
Hemoptysis 3 3
Drug Resistant Bacterial Infection 3 3
Pneumothorax 3 3
Fall 2 2
Pneumonia 2 2
Fatigue 2 2
Respiratory Failure 2 2
Hypersensitivity/Allergic reaction 2 2
Needle Stick/Puncture 1 1
Cardiac Arrest 1 1
Rupture 1 1
Anemia 1 1
Chest Pain 1 1
Pleural Effusion 1 1
Discomfort 1 1
Malaise 1 1
Perforation 1 1
Dyspnea 1 1
Laceration(s) 1 1
Renal Impairment 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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