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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device unit, electrosurgical, endoscopic (with or without accessories)
Product CodeKNS
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
ANREI MEDICAL (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AQUA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CREO MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
CREO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT - KIT 1
G-FLEX EUROPE SPRL
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LAMIDEY NOURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NXTHERA (A BOSTON SCIENTIFIC COMPANY)
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
STARMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SUMITOMO BAKELITE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 668 668
2020 906 906
2021 814 814
2022 914 914
2023 979 979
2024 790 790

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2434 2434
Adverse Event Without Identified Device or Use Problem 1260 1260
Detachment of Device or Device Component 271 271
Material Deformation 192 192
Material Separation 176 176
Material Split, Cut or Torn 160 160
Device Dislodged or Dislocated 93 93
Failure to Align 90 90
Positioning Problem 80 80
Peeled/Delaminated 75 75
Off-Label Use 72 72
Melted 70 70
Material Twisted/Bent 60 60
Mechanical Problem 58 58
Use of Device Problem 52 52
Failure to Conduct 51 51
Failure to Deliver Energy 51 51
Material Integrity Problem 51 51
Failure to Fold 48 48
Defective Device 48 48
Malposition of Device 47 47
Insufficient Information 40 40
Device Contamination with Chemical or Other Material 33 33
Material Fragmentation 30 30
Retraction Problem 29 29
Failure to Cut 27 27
Difficult to Advance 26 26
Appropriate Term/Code Not Available 22 22
Sparking 22 22
Fracture 22 22
Sharp Edges 20 20
Crack 14 14
Device Displays Incorrect Message 13 13
Output Problem 12 12
Pressure Problem 11 11
Improper or Incorrect Procedure or Method 11 11
Therapeutic or Diagnostic Output Failure 10 10
Temperature Problem 9 9
Physical Resistance/Sticking 9 9
Tear, Rip or Hole in Device Packaging 9 9
Difficult to Remove 8 8
Unsealed Device Packaging 8 8
Thermal Decomposition of Device 7 7
Material Protrusion/Extrusion 7 7
Device Fell 6 6
Material Frayed 6 6
No Device Output 6 6
Component Missing 6 6
Problem with Sterilization 5 5
Leak/Splash 5 5
Energy Output Problem 5 5
Contamination 5 5
Infusion or Flow Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Packaging Problem 5 5
Activation, Positioning or Separation Problem 4 4
Deformation Due to Compressive Stress 4 4
Electrical /Electronic Property Problem 4 4
Failure to Prime 4 4
Obstruction of Flow 4 4
Structural Problem 3 3
Device Damaged Prior to Use 3 3
Failure to Power Up 3 3
Nonstandard Device 3 3
Device-Device Incompatibility 3 3
Output below Specifications 3 3
Activation Failure 3 3
Activation Problem 3 3
Difficult to Open or Close 2 2
Impedance Problem 2 2
Flare or Flash 2 2
Unintended System Motion 2 2
Fluid/Blood Leak 2 2
Loose or Intermittent Connection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Entrapment of Device 2 2
Overheating of Device 2 2
Material Puncture/Hole 2 2
Electro-Static Discharge 2 2
Device Slipped 2 2
Defective Component 2 2
Dull, Blunt 2 2
Failure to Advance 2 2
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Malfunction 1 1
Failure to Deliver 1 1
Smoking 1 1
Material Rupture 1 1
Product Quality Problem 1 1
Premature Activation 1 1
Fire 1 1
Loss of or Failure to Bond 1 1
Failure to Capture 1 1
Device Reprocessing Problem 1 1
Complete Blockage 1 1
Positioning Failure 1 1
Disconnection 1 1
Material Disintegration 1 1
Inadequate Instructions for Healthcare Professional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2510 2510
No Consequences Or Impact To Patient 1060 1060
Perforation 415 415
Hemorrhage/Bleeding 359 359
Pain 120 120
Urinary Retention 119 119
Foreign Body In Patient 105 105
No Known Impact Or Consequence To Patient 102 102
Insufficient Information 84 84
Hematuria 73 73
Urinary Tract Infection 69 69
Micturition Urgency 62 62
Dysuria 58 58
Urinary Frequency 49 49
Patient Problem/Medical Problem 45 45
Pancreatitis 44 44
Fever 43 43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 43 43
Inflammation 40 40
Gastrointestinal Hemorrhage 37 37
Stenosis 37 37
Unspecified Infection 36 36
No Code Available 34 34
Bowel Perforation 27 27
No Patient Involvement 27 27
Unspecified Tissue Injury 27 27
Sepsis 25 25
Abdominal Pain 24 24
Blood Loss 24 24
Urinary Incontinence 24 24
Bacterial Infection 23 23
Discomfort 22 22
Necrosis 20 20
Incontinence 18 18
Injury 17 17
Swelling/ Edema 17 17
Unspecified Hepatic or Biliary Problem 15 15
Peritonitis 15 15
Obstruction/Occlusion 15 15
Internal Organ Perforation 14 14
Scar Tissue 13 13
Abscess 12 12
Perforation of Esophagus 12 12
Stenosis of the esophagus 12 12
Device Embedded In Tissue or Plaque 11 11
Burn(s) 11 11
Fistula 10 10
Unspecified Kidney or Urinary Problem 10 10
Erectile Dysfunction 10 10
Muscle Spasm(s) 9 9
Hematoma 8 8
Pleural Effusion 8 8
Hemostasis 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Sexual Dysfunction 8 8
Urethral Stenosis/Stricture 8 8
Syncope/Fainting 7 7
Burning Sensation 7 7
Death 6 6
Pneumothorax 6 6
Impotence 6 6
Muscle/Tendon Damage 6 6
Pneumonia 5 5
Complaint, Ill-Defined 5 5
Unspecified Gastrointestinal Problem 5 5
Aspiration Pneumonitis 4 4
No Information 4 4
Electric Shock 4 4
Thromboembolism 4 4
Needle Stick/Puncture 4 4
Chills 4 4
Dizziness 4 4
Nausea 4 4
Laceration(s) 4 4
Chest Pain 4 4
Skin Inflammation/ Irritation 4 4
Bradycardia 3 3
Edema 3 3
Pulmonary Embolism 3 3
Occlusion 3 3
Renal Failure 3 3
Anxiety 3 3
Vomiting 3 3
Laceration(s) of Esophagus 3 3
Depression 3 3
Numbness 3 3
Fluid Discharge 3 3
Unspecified Respiratory Problem 3 3
Hematemesis 3 3
Melena 2 2
Constipation 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Embolism/Embolus 2 2
Thrombosis/Thrombus 2 2
Diaphoresis 2 2
Cognitive Changes 2 2
Loss of consciousness 2 2
Respiratory Failure 2 2
Weakness 2 2
Twitching 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Jul-12-2024
3 Boston Scientific Corporation II Apr-18-2023
4 Boston Scientific Corporation II Mar-11-2022
5 Olympus Corporation of the Americas II Apr-05-2024
6 Wilson-Cook Medical Inc. II Apr-12-2019
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