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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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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 699 699

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2404 2404
Adverse Event Without Identified Device or Use Problem 1216 1216
Detachment of Device or Device Component 262 262
Material Deformation 189 189
Material Separation 174 174
Material Split, Cut or Torn 159 159
Device Dislodged or Dislocated 93 93
Failure to Align 89 89
Positioning Problem 80 80
Off-Label Use 72 72
Peeled/Delaminated 70 70
Melted 70 70
Material Twisted/Bent 60 60
Mechanical Problem 57 57
Failure to Conduct 51 51
Failure to Deliver Energy 51 51
Use of Device Problem 51 51
Material Integrity Problem 51 51
Failure to Fold 48 48
Malposition of Device 47 47
Defective Device 46 46
Insufficient Information 40 40
Device Contamination with Chemical or Other Material 33 33
Material Fragmentation 30 30
Failure to Cut 27 27
Retraction Problem 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 12 12
Output Problem 12 12
Pressure Problem 11 11
Improper or Incorrect Procedure or Method 11 11
Tear, Rip or Hole in Device Packaging 9 9
Physical Resistance/Sticking 9 9
Temperature Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
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
Obstruction of Flow 4 4
Failure to Prime 4 4
Failure to Power Up 3 3
Structural Problem 3 3
Electrical /Electronic Property Problem 3 3
Nonstandard Device 3 3
Device-Device Incompatibility 3 3
Activation Failure 3 3
Activation Problem 3 3
Output below Specifications 2 2
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
Labelling, Instructions for Use or Training Problem 2 2
Entrapment of Device 2 2
Dull, Blunt 2 2
Failure to Advance 2 2
Overheating of Device 2 2
Material Puncture/Hole 2 2
Electro-Static Discharge 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Device Slipped 2 2
Smoking 1 1
Material Rupture 1 1
Product Quality Problem 1 1
Premature Activation 1 1
Separation Failure 1 1
Patient-Device Incompatibility 1 1
Malfunction 1 1
Failure to Deliver 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
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2461 2461
No Consequences Or Impact To Patient 1060 1060
Perforation 415 415
Hemorrhage/Bleeding 352 352
Pain 114 114
Urinary Retention 107 107
No Known Impact Or Consequence To Patient 102 102
Foreign Body In Patient 101 101
Insufficient Information 83 83
Hematuria 61 61
Urinary Tract Infection 58 58
Micturition Urgency 58 58
Dysuria 47 47
Patient Problem/Medical Problem 45 45
Urinary Frequency 45 45
Pancreatitis 44 44
Fever 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Inflammation 37 37
Stenosis 37 37
Gastrointestinal Hemorrhage 36 36
Unspecified Infection 36 36
No Code Available 34 34
Bowel Perforation 27 27
No Patient Involvement 27 27
Blood Loss 24 24
Sepsis 23 23
Abdominal Pain 23 23
Unspecified Tissue Injury 23 23
Bacterial Infection 22 22
Discomfort 21 21
Urinary Incontinence 21 21
Incontinence 18 18
Injury 17 17
Necrosis 16 16
Peritonitis 15 15
Obstruction/Occlusion 15 15
Unspecified Hepatic or Biliary Problem 15 15
Swelling/ Edema 15 15
Internal Organ Perforation 13 13
Scar Tissue 12 12
Abscess 12 12
Perforation of Esophagus 12 12
Burn(s) 11 11
Stenosis of the esophagus 10 10
Erectile Dysfunction 10 10
Device Embedded In Tissue or Plaque 10 10
Muscle Spasm(s) 9 9
Hemostasis 8 8
Hematoma 7 7
Urethral Stenosis/Stricture 7 7
Unspecified Kidney or Urinary Problem 7 7
Sexual Dysfunction 6 6
Burning Sensation 6 6
Impotence 6 6
Death 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Muscle/Tendon Damage 6 6
Unspecified Gastrointestinal Problem 5 5
Pleural Effusion 5 5
Pneumonia 5 5
Complaint, Ill-Defined 5 5
Chills 4 4
Needle Stick/Puncture 4 4
Aspiration Pneumonitis 4 4
No Information 4 4
Thromboembolism 4 4
Electric Shock 4 4
Laceration(s) 4 4
Nausea 4 4
Fistula 4 4
Edema 3 3
Pulmonary Embolism 3 3
Bradycardia 3 3
Chest Pain 3 3
Occlusion 3 3
Pneumothorax 3 3
Renal Failure 3 3
Fluid Discharge 3 3
Syncope/Fainting 3 3
Unspecified Respiratory Problem 3 3
Hematemesis 3 3
Numbness 3 3
Laceration(s) of Esophagus 3 3
Dizziness 3 3
Vomiting 3 3
Anxiety 3 3
Ulcer 2 2
Weakness 2 2
Dysphasia 2 2
Twitching 2 2
Depression 2 2
Loss of consciousness 2 2
Respiratory Failure 2 2
Diaphoresis 2 2
Cognitive Changes 2 2
Melena 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Embolism/Embolus 2 2
Thrombosis/Thrombus 2 2

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