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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
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 2
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 919 919
2024 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 304 304
Break 299 299
No Display/Image 284 284
Device Reprocessing Problem 254 254
Fluid/Blood Leak 158 158
Failure to Clean Adequately 156 156
Detachment of Device or Device Component 116 116
Erratic or Intermittent Display 100 100
Adverse Event Without Identified Device or Use Problem 98 98
Failure to Power Up 69 69
Electrical /Electronic Property Problem 68 68
Loose or Intermittent Connection 65 65
Poor Quality Image 65 65
Contamination 52 52
Contamination /Decontamination Problem 52 52
Material Split, Cut or Torn 52 52
Insufficient Information 43 43
Peeled/Delaminated 42 42
Mechanical Problem 38 38
Material Separation 31 31
Leak/Splash 29 29
Display or Visual Feedback Problem 27 27
Material Deformation 26 26
Power Problem 25 25
Grounding Malfunction 23 23
Optical Obstruction 22 22
Scratched Material 22 22
Connection Problem 20 20
Component Missing 20 20
Crack 19 19
Unintended Movement 19 19
Output Problem 19 19
Material Protrusion/Extrusion 18 18
Improper or Incorrect Procedure or Method 18 18
Defective Component 17 17
Material Discolored 16 16
Defective Device 15 15
No Device Output 15 15
Material Integrity Problem 15 15
Material Twisted/Bent 14 14
Image Display Error/Artifact 14 14
Optical Problem 12 12
Material Fragmentation 10 10
Corroded 9 9
Obstruction of Flow 9 9
Material Rupture 9 9
Device Contamination with Chemical or Other Material 9 9
Optical Distortion 9 9
No Visual Prompts/Feedback 9 9
Key or Button Unresponsive/not Working 9 9
Unexpected Shutdown 8 8
Deformation Due to Compressive Stress 8 8
Mechanical Jam 7 7
Communication or Transmission Problem 6 6
Use of Device Problem 6 6
Loss of Power 6 6
Difficult to Remove 6 6
Fracture 6 6
Degraded 6 6
Device Dislodged or Dislocated 5 5
Electrical Power Problem 5 5
Device Fell 5 5
Device Handling Problem 4 4
Physical Resistance/Sticking 4 4
Separation Problem 4 4
Temperature 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
Overheating of Device 3 3
Circuit Failure 3 3
Labelling, Instructions for Use or Training Problem 3 3
Material Disintegration 3 3
Arcing 3 3
Excessive Heating 3 3
Complete Loss of Power 2 2
Intermittent Loss of Power 2 2
Noise, Audible 2 2
Device Contaminated at the User Facility 2 2
Electrical Shorting 2 2
Device Damaged by Another Device 2 2
Difficult to Insert 2 2
Flaked 2 2
Calcified 2 2
Complete Blockage 2 2
Accessory Incompatible 2 2
Disconnection 2 2
Failure to Disinfect 2 2
Product Quality Problem 2 2
Device Damaged Prior to Use 2 2
Sparking 2 2
Structural Problem 2 2
Failure to Advance 2 2
Dent in Material 1 1
Separation Failure 1 1
Blocked Connection 1 1
Failure to Read Input Signal 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1921 1921
No Consequences Or Impact To Patient 231 231
Urinary Tract Infection 144 144
No Patient Involvement 133 133
Unspecified Infection 82 82
Sepsis 65 65
Bacterial Infection 61 61
No Known Impact Or Consequence To Patient 54 54
Insufficient Information 47 47
Fever 43 43
Pain 29 29
Inflammation 15 15
Urinary Frequency 14 14
Foreign Body In Patient 14 14
Chills 11 11
Nausea 8 8
Hemorrhage/Bleeding 7 7
Hematuria 6 6
Electric Shock 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Patient Problem/Medical Problem 4 4
Burn(s) 4 4
Urinary Retention 4 4
Pneumothorax 3 3
Viral Infection 3 3
Burning Sensation 3 3
Hemoptysis 3 3
Injury 3 3
Unspecified Tissue Injury 3 3
Unspecified Kidney or Urinary Problem 2 2
Drug Resistant Bacterial Infection 2 2
Respiratory Failure 2 2
Dysuria 2 2
Laceration(s) 2 2
Perforation 2 2
Pneumonia 2 2
Local Reaction 1 1
Renal Failure 1 1
Shock 1 1
Skin Discoloration 1 1
Swelling 1 1
Tissue Damage 1 1
Rupture 1 1
Discomfort 1 1
Pleural Effusion 1 1
Internal Organ Perforation 1 1
Hypersensitivity/Allergic reaction 1 1
Syncope 1 1
Hematoma 1 1
Cardiac Arrest 1 1
Death 1 1
Dyspnea 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
No Code Available 1 1
Renal Impairment 1 1
Blood Loss 1 1
Pseudoaneurysm 1 1
Malaise 1 1
Numbness 1 1
Needle Stick/Puncture 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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