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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
  1.  K171993  Zimmon Needle Knife Papillotome
  2.  K172665  Classic Cotton Cannulatome®, CannulaTome II® Doubl ...

MDR Year MDR Reports MDR Events
2015 406 406
2016 457 457
2017 446 446
2018 563 563
2019 668 668
2020 686 686

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1059 1059
Failure to Align 503 503
Adverse Event Without Identified Device or Use Problem 489 489
Failure to Deliver Energy 213 213
Material Separation 187 187
Probe 108 108
Peeled/Delaminated 107 107
Wire 104 104
Positioning Problem 100 100
Retraction Problem 72 72
Generator 68 68
Detachment of Device or Device Component 56 56
Tip 55 55
Failure to Conduct 48 48
Use of Device Problem 37 37
Failure to Cut 37 37
Migration or Expulsion of Device 37 37
Detachment Of Device Component 34 34
Malposition of Device 34 34
Electrode 32 32
Needle 30 30
Off-Label Use 27 27
Device Operates Differently Than Expected 27 27
Device Displays Incorrect Message 26 26
Material Twisted/Bent 21 21
Material Deformation 18 18
Device Dislodged or Dislocated 17 17
Material Protrusion/Extrusion 15 15
Output Problem 15 15
Material Fragmentation 15 15
Device Reprocessing Problem 14 14
Device Handling Problem 14 14
Insufficient Information 13 13
Improper or Incorrect Procedure or Method 12 12
Failure to Fold 11 11
Material Frayed 10 10
Device Contamination with Chemical or Other Material 10 10
Appropriate Term/Code Not Available 10 10
Catheter 10 10
Defective Device 9 9
Cord 9 9
Mechanical Problem 9 9
Material Split, Cut or Torn 9 9
Sharp Edges 9 9
Material Integrity Problem 8 8
Device Inoperable 8 8
Connector 8 8
Difficult to Advance 7 7
Fracture 7 7
Sparking 7 7
Component Missing 6 6
Difficult to Remove 6 6
Crack 6 6
No Device Output 5 5
Ball 5 5
Device Damaged Prior to Use 4 4
Defective Component 4 4
Tear, Rip or Hole in Device Packaging 4 4
Thermal Decomposition of Device 4 4
Electrical /Electronic Property Problem 4 4
Electrical Shorting 4 4
Mechanics Altered 4 4
Material Puncture/Hole 4 4
Foot Switch 4 4
Activation, Positioning or SeparationProblem 4 4
Split 3 3
Bent 3 3
Unsealed Device Packaging 3 3
Melted 3 3
Energy Output To Patient Tissue Incorrect 3 3
No Apparent Adverse Event 3 3
Unintended Movement 3 3
Physical Resistance/Sticking 3 3
Contamination 3 3
Guidewire 3 3
Loose or Intermittent Connection 3 3
Failure to Advance 3 3
Difficult to Insert 2 2
Sticking 2 2
Insufficient Heating 2 2
Port 2 2
Component Falling 2 2
Device Fell 2 2
Handpiece 2 2
Material Distortion 2 2
Overheating of Device 2 2
Failure to Power Up 2 2
Inadequate Instructions for Healthcare Professional 2 2
Material Disintegration 2 2
Fluid Leak 2 2
Pad 2 2
Pump 2 2
Problem with Sterilization 2 2
Wire(s), breakage of 2 2
Pumping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Operating System Becomes Nonfunctional 2 2
Infusion or Flow Problem 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2312 2312
No Known Impact Or Consequence To Patient 309 309
Perforation 196 196
Foreign Body In Patient 61 61
Hemorrhage/Bleeding 48 48
No Patient Involvement 47 47
Blood Loss 42 42
No Code Available 41 41
Pain 41 41
Patient Problem/Medical Problem 39 39
Urinary Tract Infection 25 25
Urinary Retention 24 24
No Information 24 24
Device Embedded In Tissue or Plaque 23 23
Inflammation 21 21
Hematuria 19 19
Dysuria 19 19
Injury 19 19
Hemostasis 16 16
Incontinence 14 14
Stenosis 14 14
Discomfort 12 12
Micturition Urgency 12 12
Death 10 10
Unspecified Infection 9 9
Muscle Spasm(s) 9 9
Sepsis 8 8
Fever 8 8
Tissue Damage 7 7
Burn(s) 6 6
Urinary Frequency 6 6
Internal Organ Perforation 5 5
Burn, Thermal 5 5
Electric Shock 5 5
Complaint, Ill-Defined 4 4
Perforation of Esophagus 4 4
Bowel Burn 4 4
Impotence 4 4
Abscess 3 3
Chills 3 3
Occlusion 3 3
Bowel Perforation 3 3
Necrosis 3 3
Edema 3 3
Bacterial Infection 3 3
Needle Stick/Puncture 3 3
Myocardial Infarction 2 2
Dysphasia 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
No Clinical Signs, Symptoms or Conditions 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
Intraoperative Pain 1 1
Not Applicable 1 1
Constipation 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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