• 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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
CREO MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
CREO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT - KIT 1
EMCISION LTD.
  SUBSTANTIALLY EQUIVALENT 1
G-FLEX EUROPE SPRL
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LAMIDEY NOURY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NXTHERA (A BOSTON SCIENTIFIC COMPANY)
  SUBSTANTIALLY EQUIVALENT 2
NXTHERA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
STARMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SUMITOMO BAKELITE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2
WILSON-COOK MEDICAL, INC./ COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 446 446
2018 563 563
2019 668 668
2020 906 906
2021 815 815
2022 634 634

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1716 1716
Adverse Event Without Identified Device or Use Problem 880 880
Failure to Align 282 282
Material Separation 193 193
Positioning Problem 130 130
Failure to Deliver Energy 116 116
Detachment of Device or Device Component 82 82
Material Deformation 77 77
Peeled/Delaminated 71 71
Retraction Problem 63 63
Failure to Conduct 56 56
Off-Label Use 53 53
Use of Device Problem 50 50
Device Dislodged or Dislocated 50 50
Malposition of Device 49 49
Material Twisted/Bent 46 46
Failure to Fold 36 36
Insufficient Information 35 35
Failure to Cut 31 31
Mechanical Problem 30 30
Material Split, Cut or Torn 28 28
Material Integrity Problem 27 27
Defective Device 26 26
Melted 23 23
Material Fragmentation 23 23
Appropriate Term/Code Not Available 22 22
Migration or Expulsion of Device 18 18
Difficult to Advance 15 15
Device Reprocessing Problem 14 14
Detachment Of Device Component 14 14
Fracture 13 13
Device Contamination with Chemical or Other Material 13 13
Output Problem 13 13
Sharp Edges 12 12
Device Displays Incorrect Message 12 12
Improper or Incorrect Procedure or Method 12 12
Device Operates Differently Than Expected 11 11
Material Protrusion/Extrusion 10 10
Device Handling Problem 7 7
Difficult to Remove 7 7
Contamination 7 7
Unsealed Device Packaging 7 7
Material Frayed 7 7
No Device Output 6 6
Tear, Rip or Hole in Device Packaging 6 6
Sparking 6 6
Activation, Positioning or SeparationProblem 6 6
Infusion or Flow Problem 5 5
Pressure Problem 5 5
Physical Resistance/Sticking 5 5
Therapeutic or Diagnostic Output Failure 5 5
Problem with Sterilization 5 5
Device Damaged Prior to Use 4 4
Obstruction of Flow 4 4
Component Missing 4 4
Crack 4 4
Unintended Movement 4 4
Device Fell 4 4
Packaging Problem 4 4
Deformation Due to Compressive Stress 4 4
Temperature Problem 3 3
Device-Device Incompatibility 3 3
Electrical /Electronic Property Problem 3 3
Fluid Leak 3 3
Leak/Splash 3 3
Structural Problem 3 3
Failure to Advance 3 3
Defective Component 3 3
Material Puncture/Hole 3 3
Failure to Power Up 2 2
Device Slipped 2 2
Device Inoperable 2 2
Loose or Intermittent Connection 2 2
Difficult to Insert 2 2
Insufficient Heating 2 2
Energy Output Problem 2 2
Nonstandard Device 2 2
Material Disintegration 2 2
Thermal Decomposition of Device 2 2
Operating System Becomes Nonfunctional 2 2
Device Contaminated During Manufacture or Shipping 2 2
Output below Specifications 2 2
Wire(s), breakage of 2 2
Activation Failure 2 2
No Apparent Adverse Event 1 1
Intermittent Energy Output 1 1
Activation Problem 1 1
Unclear Information 1 1
Device Markings/Labelling Problem 1 1
Capturing Problem 1 1
Component or Accessory Incompatibility 1 1
Patient-Device Incompatibility 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Difficult to Open or Close 1 1
Improper Device Output 1 1
Electrical Shorting 1 1
Pumping Problem 1 1
Power Problem 1 1
Optical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1852 1852
No Clinical Signs, Symptoms or Conditions 977 977
Perforation 318 318
No Known Impact Or Consequence To Patient 197 197
Hemorrhage/Bleeding 176 176
Pain 79 79
Foreign Body In Patient 78 78
Urinary Retention 61 61
Insufficient Information 58 58
No Patient Involvement 50 50
No Code Available 48 48
Patient Problem/Medical Problem 45 45
Blood Loss 43 43
Urinary Tract Infection 39 39
Hematuria 34 34
Inflammation 32 32
Dysuria 29 29
Stenosis 27 27
Micturition Urgency 27 27
Urinary Frequency 24 24
Gastrointestinal Hemorrhage 22 22
Unspecified Infection 22 22
Sepsis 19 19
Discomfort 19 19
Injury 18 18
Pancreatitis 18 18
Incontinence 17 17
Abdominal Pain 17 17
Fever 16 16
No Information 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Device Embedded In Tissue or Plaque 13 13
Hemostasis 13 13
Peritonitis 12 12
Burn(s) 11 11
Abscess 10 10
Unspecified Tissue Injury 10 10
Bowel Perforation 10 10
Stenosis of the esophagus 10 10
Unspecified Hepatic or Biliary Problem 9 9
Perforation of Esophagus 9 9
Death 9 9
Muscle Spasm(s) 9 9
Necrosis 9 9
Swelling/ Edema 8 8
Urinary Incontinence 7 7
Scar Tissue 7 7
Impotence 6 6
Erectile Dysfunction 6 6
Obstruction/Occlusion 6 6
Complaint, Ill-Defined 5 5
Needle Stick/Puncture 5 5
Pleural Effusion 5 5
Pneumonia 4 4
Hematoma 4 4
Edema 4 4
Bacterial Infection 4 4
Chills 4 4
Cramp(s) /Muscle Spasm(s) 4 4
Muscle/Tendon Damage 3 3
Unspecified Gastrointestinal Problem 3 3
Aspiration Pneumonitis 3 3
Dizziness 3 3
Laceration(s) of Esophagus 3 3
Burn, Thermal 3 3
Electric Shock 3 3
Thromboembolism 3 3
Occlusion 3 3
Internal Organ Perforation 3 3
Nausea 3 3
Tissue Damage 3 3
Burning Sensation 3 3
Twitching 2 2
Thrombosis 2 2
Vomiting 2 2
Weakness 2 2
Undesired Nerve Stimulation 2 2
Shock 2 2
Myocardial Infarction 2 2
Laceration(s) 2 2
Pneumothorax 2 2
Bradycardia 2 2
Aspiration/Inhalation 2 2
Anemia 2 2
Dehydration 2 2
Chest Pain 2 2
Fistula 2 2
Pulmonary Embolism 2 2
Fatigue 2 2
Fluid Discharge 2 2
Diaphoresis 2 2
Dysphasia 2 2
Anxiety 2 2
Unspecified Respiratory Problem 2 2
Urethral Stenosis/Stricture 2 2
Unspecified Reproductive System or Breast Problem 2 2
Skin Inflammation/ Irritation 1 1
Restenosis 1 1
Unspecified Kidney or Urinary Problem 1 1
Sexual Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Mar-11-2022
3 NXTHERA II Dec-18-2017
4 Wilson-Cook Medical Inc. II Apr-12-2019
-
-