Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 555 555

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2339 2339
Adverse Event Without Identified Device or Use Problem 1186 1186
Detachment of Device or Device Component 246 246
Material Deformation 186 186
Material Separation 170 170
Material Split, Cut or Torn 155 155
Device Dislodged or Dislocated 90 90
Failure to Align 89 89
Positioning Problem 80 80
Off-Label Use 71 71
Peeled/Delaminated 70 70
Melted 68 68
Material Twisted/Bent 60 60
Mechanical Problem 56 56
Use of Device Problem 51 51
Material Integrity Problem 51 51
Failure to Conduct 50 50
Failure to Deliver Energy 48 48
Failure to Fold 48 48
Malposition of Device 47 47
Defective Device 43 43
Insufficient Information 40 40
Material Fragmentation 30 30
Failure to Cut 27 27
Retraction Problem 25 25
Difficult to Advance 23 23
Appropriate Term/Code Not Available 22 22
Sparking 22 22
Fracture 22 22
Sharp Edges 19 19
Device Contamination with Chemical or Other Material 17 17
Output Problem 12 12
Crack 12 12
Device Displays Incorrect Message 12 12
Improper or Incorrect Procedure or Method 11 11
Pressure Problem 11 11
Physical Resistance/Sticking 9 9
Tear, Rip or Hole in Device Packaging 9 9
Difficult to Remove 8 8
Unsealed Device Packaging 8 8
Therapeutic or Diagnostic Output Failure 8 8
Temperature Problem 7 7
Material Protrusion/Extrusion 7 7
Thermal Decomposition of Device 7 7
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
Device Fell 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 2335 2335
No Consequences Or Impact To Patient 1060 1060
Perforation 410 410
Hemorrhage/Bleeding 348 348
Pain 112 112
Urinary Retention 104 104
No Known Impact Or Consequence To Patient 102 102
Foreign Body In Patient 98 98
Insufficient Information 82 82
Hematuria 60 60
Urinary Tract Infection 58 58
Micturition Urgency 57 57
Dysuria 46 46
Patient Problem/Medical Problem 45 45
Pancreatitis 44 44
Urinary Frequency 43 43
Fever 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Stenosis 37 37
Inflammation 36 36
Unspecified Infection 35 35
Gastrointestinal Hemorrhage 35 35
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
Bacterial Infection 22 22
Discomfort 21 21
Unspecified Tissue Injury 21 21
Urinary Incontinence 20 20
Incontinence 18 18
Injury 17 17
Necrosis 16 16
Peritonitis 15 15
Unspecified Hepatic or Biliary Problem 15 15
Swelling/ Edema 15 15
Obstruction/Occlusion 14 14
Internal Organ Perforation 13 13
Abscess 12 12
Perforation of Esophagus 12 12
Burn(s) 11 11
Scar Tissue 11 11
Stenosis of the esophagus 10 10
Erectile Dysfunction 10 10
Device Embedded In Tissue or Plaque 9 9
Muscle Spasm(s) 9 9
Hemostasis 8 8
Hematoma 7 7
Urethral Stenosis/Stricture 7 7
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
Unspecified Kidney or Urinary Problem 5 5
Sexual Dysfunction 5 5
Complaint, Ill-Defined 5 5
Burning Sensation 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
-
-