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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device unit, electrosurgical, endoscopic (with or without accessories)
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeKNS
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
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
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 905 905
2021 814 814

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1448 1448
Adverse Event Without Identified Device or Use Problem 647 647
Failure to Align 281 281
Material Separation 164 164
Positioning Problem 129 129
Failure to Deliver Energy 115 115
Peeled/Delaminated 65 65
Detachment of Device or Device Component 64 64
Retraction Problem 59 59
Material Deformation 52 52
Malposition of Device 48 48
Off-Label Use 47 47
Failure to Conduct 45 45
Use of Device Problem 43 43
Material Twisted/Bent 41 41
Device Dislodged or Dislocated 33 33
Insufficient Information 31 31
Failure to Cut 28 28
Failure to Fold 24 24
Material Integrity Problem 22 22
Appropriate Term/Code Not Available 21 21
Mechanical Problem 21 21
Defective Device 19 19
Migration or Expulsion of Device 18 18
Material Fragmentation 15 15
Device Reprocessing Problem 14 14
Detachment Of Device Component 14 14
Material Split, Cut or Torn 14 14
Improper or Incorrect Procedure or Method 12 12
Fracture 11 11
Output Problem 11 11
Device Operates Differently Than Expected 11 11
Sharp Edges 11 11
Material Protrusion/Extrusion 10 10
Difficult to Advance 9 9
Device Displays Incorrect Message 9 9
Device Contamination with Chemical or Other Material 8 8
Device Handling Problem 7 7
Contamination 7 7
Material Frayed 7 7
Unsealed Device Packaging 7 7
No Device Output 6 6
Activation, Positioning or SeparationProblem 6 6
Difficult to Remove 6 6
Problem with Sterilization 5 5
Tear, Rip or Hole in Device Packaging 5 5
Melted 5 5
Deformation Due to Compressive Stress 4 4
Sparking 4 4
Device Damaged Prior to Use 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 4 4
Packaging Problem 4 4
Physical Resistance/Sticking 3 3
Infusion or Flow Problem 3 3
Device Fell 3 3
Temperature Problem 3 3
Defective Component 3 3
Component Missing 3 3
Material Puncture/Hole 3 3
Obstruction of Flow 3 3
Failure to Advance 3 3
Fluid Leak 3 3
Crack 3 3
Electrical /Electronic Property Problem 3 3
Material Disintegration 2 2
Thermal Decomposition of Device 2 2
Loose or Intermittent Connection 2 2
Nonstandard Device 2 2
Insufficient Heating 2 2
Difficult to Insert 2 2
Structural Problem 2 2
Wire(s), breakage of 2 2
Failure to Power Up 2 2
Device Inoperable 2 2
Device-Device Incompatibility 2 2
Operating System Becomes Nonfunctional 2 2
Activation Failure 2 2
Output below Specifications 2 2
Pressure Problem 2 2
Pumping Problem 1 1
Power Problem 1 1
No Apparent Adverse Event 1 1
Optical Problem 1 1
Improper Device Output 1 1
Difficult to Open or Close 1 1
Electrical Shorting 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Intermittent Energy Output 1 1
Unclear Information 1 1
Unexpected Therapeutic Results 1 1
Failure to Deliver 1 1
Failure to Prime 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Device Slipped 1 1
Smoking 1 1
Component or Accessory Incompatibility 1 1
Malfunction 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 595 595
Perforation 245 245
No Known Impact Or Consequence To Patient 197 197
Hemorrhage/Bleeding 85 85
Pain 59 59
Foreign Body In Patient 55 55
No Patient Involvement 50 50
No Code Available 48 48
Patient Problem/Medical Problem 45 45
Blood Loss 43 43
Urinary Retention 41 41
Urinary Tract Infection 34 34
Insufficient Information 32 32
Hematuria 25 25
Inflammation 25 25
Dysuria 24 24
Micturition Urgency 22 22
Injury 18 18
Incontinence 17 17
Urinary Frequency 16 16
Discomfort 16 16
No Information 16 16
Stenosis 15 15
Device Embedded In Tissue or Plaque 13 13
Hemostasis 13 13
Gastrointestinal Hemorrhage 12 12
Unspecified Infection 11 11
Sepsis 11 11
Muscle Spasm(s) 9 9
Fever 9 9
Death 9 9
Perforation of Esophagus 9 9
Bowel Perforation 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Abdominal Pain 8 8
Abscess 8 8
Burn(s) 8 8
Necrosis 8 8
Impotence 6 6
Complaint, Ill-Defined 5 5
Swelling/ Edema 5 5
Needle Stick/Puncture 5 5
Erectile Dysfunction 5 5
Unspecified Tissue Injury 5 5
Pancreatitis 4 4
Chills 4 4
Edema 4 4
Bacterial Infection 3 3
Tissue Damage 3 3
Occlusion 3 3
Internal Organ Perforation 3 3
Stenosis of the esophagus 3 3
Burn, Thermal 3 3
Electric Shock 3 3
Obstruction/Occlusion 2 2
Urinary Incontinence 2 2
Unspecified Reproductive System or Breast Problem 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Pleural Effusion 2 2
Pneumothorax 2 2
Thrombosis 2 2
Scar Tissue 2 2
Dizziness 2 2
Peritonitis 2 2
Weakness 2 2
Burning Sensation 2 2
Anxiety 2 2
Anemia 2 2
Chest Pain 2 2
Pulmonary Embolism 2 2
Fatigue 2 2
Dehydration 2 2
Hematoma 2 2
Undesired Nerve Stimulation 2 2
Myocardial Infarction 2 2
Laceration(s) 2 2
Nausea 1 1
Hyperplasia 1 1
Fistula 1 1
Headache 1 1
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Pulmonary Emphysema 1 1
Endocarditis 1 1
Corneal Perforation 1 1
Stroke/CVA 1 1
Infarction, Cerebral 1 1
Bowel Burn 1 1
Depression 1 1
Disability 1 1
Laceration(s) of Esophagus 1 1
Twitching 1 1
Vomiting 1 1
Dysphasia 1 1
Skin Discoloration 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1

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