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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
COOK (CANADA), INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS COPR.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUMITOMO BAKELITE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 406 406
2016 457 457
2017 446 446
2018 563 563
2019 668 668
2020 592 592

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1006 1006
Failure to Align 498 498
Adverse Event Without Identified Device or Use Problem 479 479
Failure to Deliver Energy 213 213
Material Separation 182 182
Probe 108 108
Peeled/Delaminated 106 106
Wire 104 104
Positioning Problem 92 92
Retraction Problem 72 72
Generator 68 68
Tip 55 55
Detachment of Device or Device Component 55 55
Failure to Conduct 48 48
Migration or Expulsion of Device 37 37
Use of Device Problem 37 37
Failure to Cut 36 36
Detachment Of Device Component 34 34
Electrode 32 32
Needle 30 30
Malposition of Device 29 29
Device Operates Differently Than Expected 27 27
Device Displays Incorrect Message 26 26
Off-Label Use 26 26
Material Twisted/Bent 19 19
Device Dislodged or Dislocated 17 17
Material Protrusion/Extrusion 15 15
Material Deformation 15 15
Output Problem 15 15
Material Fragmentation 15 15
Device Reprocessing Problem 14 14
Device Handling Problem 14 14
Insufficient Information 12 12
Improper or Incorrect Procedure or Method 12 12
Catheter 10 10
Device Contamination with Chemical or Other Material 10 10
Material Frayed 10 10
Failure to Fold 10 10
Cord 9 9
Material Split, Cut or Torn 9 9
Sharp Edges 9 9
Appropriate Term/Code Not Available 8 8
Material Integrity Problem 8 8
Device Inoperable 8 8
Defective Device 8 8
Connector 8 8
Sparking 7 7
Difficult to Advance 7 7
Component Missing 6 6
Crack 6 6
Fracture 6 6
Mechanical Problem 6 6
Difficult to Remove 6 6
No Device Output 5 5
Ball 5 5
Foot Switch 4 4
Thermal Decomposition of Device 4 4
Material Puncture/Hole 4 4
Electrical /Electronic Property Problem 4 4
Defective Component 4 4
Device Damaged Prior to Use 4 4
Tear, Rip or Hole in Device Packaging 4 4
Electrical Shorting 4 4
Activation, Positioning or SeparationProblem 4 4
Mechanics Altered 4 4
Unintended Movement 3 3
Physical Resistance/Sticking 3 3
Failure to Advance 3 3
Split 3 3
Energy Output To Patient Tissue Incorrect 3 3
Loose or Intermittent Connection 3 3
Unsealed Device Packaging 3 3
Bent 3 3
Contamination 3 3
Guidewire 3 3
No Apparent Adverse Event 3 3
Pad 2 2
Port 2 2
Component Falling 2 2
Material Disintegration 2 2
Pump 2 2
Problem with Sterilization 2 2
Sticking 2 2
Overheating of Device 2 2
Melted 2 2
Inadequate Instructions for Healthcare Professional 2 2
Difficult to Insert 2 2
Insufficient Heating 2 2
Fluid Leak 2 2
Wire(s), breakage of 2 2
Handpiece 2 2
Material Distortion 2 2
Pumping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Torn Material 1 1
Power Problem 1 1
Packaging Problem 1 1
Operating System Becomes Nonfunctional 1 1
Output below Specifications 1 1
Improper Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2233 2233
No Known Impact Or Consequence To Patient 308 308
Perforation 195 195
Foreign Body In Patient 60 60
No Patient Involvement 46 46
Hemorrhage/Bleeding 46 46
Blood Loss 42 42
No Code Available 41 41
Pain 38 38
Patient Problem/Medical Problem 37 37
No Information 24 24
Urinary Tract Infection 24 24
Urinary Retention 23 23
Device Embedded In Tissue or Plaque 23 23
Inflammation 20 20
Hematuria 19 19
Dysuria 18 18
Injury 18 18
Hemostasis 16 16
Stenosis 14 14
Incontinence 13 13
Micturition Urgency 11 11
Discomfort 11 11
Death 10 10
Unspecified Infection 9 9
Muscle Spasm(s) 9 9
Fever 8 8
Burn(s) 6 6
Sepsis 6 6
Tissue Damage 6 6
Internal Organ Perforation 5 5
Burn, Thermal 5 5
Electric Shock 5 5
Urinary Frequency 5 5
Perforation of Esophagus 4 4
Bowel Burn 4 4
Impotence 3 3
Abscess 3 3
Chills 3 3
Occlusion 3 3
Bowel Perforation 3 3
Complaint, Ill-Defined 3 3
Necrosis 3 3
Edema 3 3
Bacterial Infection 2 2
Myocardial Infarction 2 2
Dysphasia 2 2
Needle Stick/Puncture 2 2
Peritonitis 2 2
Thrombosis 2 2
Anemia 2 2
Dehydration 2 2
Hematoma 2 2
Hyperplasia 1 1
Swelling 1 1
Oversedation 1 1
Cancer 1 1
Intraoperative Pain 1 1
Not Applicable 1 1
Constipation 1 1
Disability 1 1
Scar Tissue 1 1
Vomiting 1 1
Weakness 1 1
Burning Sensation 1 1
Dizziness 1 1
Nausea 1 1
Abdominal Pain 1 1
Laceration(s) 1 1
Bruise/Contusion 1 1
Stroke/CVA 1 1
Infarction, Cerebral 1 1
Chest Pain 1 1
Fistula 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Akita Sumitomo Bakelite Co., Ltd. II Nov-10-2016
2 NXTHERA II Dec-18-2017
3 Ultroid Technologies, Inc. II Dec-17-2016
4 Wilson-Cook Medical Inc. II Apr-12-2019
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