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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, electrosurgical, active, urological
Product CodeFAS
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
CHIRURGIE INNOVATION
  SUBSTANTIALLY EQUIVALENT 2
DORNIER MEDTECH AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 2
MODERN MEDICAL EQUIPMENT MFG., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 6
OMNITECH SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 52 52
2015 82 82
2016 69 69
2017 121 121
2018 70 70
2019 61 61
2020 99 99
2021 102 102
2022 147 147
2023 330 330
2024 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Break 648 648
Material Fragmentation 131 131
Detachment of Device or Device Component 129 129
Fracture 114 114
Mechanical Problem 106 106
Sparking 71 71
Detachment Of Device Component 55 55
Adverse Event Without Identified Device or Use Problem 48 48
Material Separation 39 39
Component Falling 30 30
Melted 25 25
Thermal Decomposition of Device 24 24
Crack 20 20
Material Twisted/Bent 20 20
Fire 17 17
Overheating of Device 17 17
Material Disintegration 16 16
Insufficient Information 15 15
Arcing of Electrodes 14 14
Arcing 13 13
Component Missing 13 13
Defective Component 12 12
Material Deformation 12 12
Device Or Device Fragments Location Unknown 11 11
Material Split, Cut or Torn 10 10
Smoking 9 9
Charred 8 8
Output Problem 8 8
Electrical Shorting 8 8
Improper or Incorrect Procedure or Method 7 7
Defective Device 7 7
Failure to Cut 6 6
Electrical /Electronic Property Problem 6 6
Device Operates Differently Than Expected 6 6
Material Integrity Problem 6 6
Unintended Electrical Shock 5 5
Excessive Heating 5 5
Use of Incorrect Control/Treatment Settings 5 5
Peeled/Delaminated 4 4
Intermittent Loss of Power 4 4
No Apparent Adverse Event 4 4
Device Damaged by Another Device 4 4
Electrical Power Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Connection Problem 3 3
Explosion 3 3
Product Quality Problem 3 3
Nonstandard Device 3 3
Bent 3 3
Disconnection 3 3
Failure to Conduct 2 2
Failure to Deliver Energy 2 2
Flaked 2 2
Electro-Static Discharge 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Device Inoperable 2 2
Material Rupture 2 2
Use of Device Problem 2 2
Dent in Material 2 2
Appropriate Term/Code Not Available 2 2
Device Handling Problem 2 2
Activation Failure 2 2
Temperature Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Dislodged or Dislocated 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Mechanical Jam 2 2
Device Fell 2 2
Failure to Clean Adequately 2 2
Activation Problem 1 1
Non Reproducible Results 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Flare or Flash 1 1
Electrical Overstress 1 1
Device Disinfection Or Sterilization Issue 1 1
Unintended Movement 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Power Problem 1 1
Noise, Audible 1 1
Sharp Edges 1 1
Fumes or Vapors 1 1
Split 1 1
Separation Failure 1 1
Failure to Deliver 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Failure to Align 1 1
Blocked Connection 1 1
Communication or Transmission Problem 1 1
Unraveled Material 1 1
Difficult to Remove 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Slipped 1 1
Loss of Power 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 505 505
No Known Impact Or Consequence To Patient 205 205
No Consequences Or Impact To Patient 191 191
Foreign Body In Patient 106 106
Insufficient Information 71 71
Device Embedded In Tissue or Plaque 23 23
Hemorrhage/Bleeding 21 21
Burn(s) 18 18
Internal Organ Perforation 14 14
Perforation 13 13
No Information 12 12
Electric Shock 11 11
No Patient Involvement 8 8
Injury 5 5
Burn, Thermal 4 4
Laceration(s) 4 4
No Code Available 4 4
Pancreatitis 4 4
Bowel Perforation 3 3
Unspecified Infection 3 3
Death 3 3
Blood Loss 3 3
Rupture 3 3
Stenosis 3 3
Hematuria 2 2
Twitching 2 2
Ecchymosis 2 2
Fever 2 2
Unspecified Gastrointestinal Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Urinary Incontinence 2 2
Full thickness (Third Degree) Burn 1 1
Shock from Patient Lead(s) 1 1
Unspecified Kidney or Urinary Problem 1 1
Genital Bleeding 1 1
Hyperextension 1 1
Blister 1 1
Skin Burning Sensation 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Constipation 1 1
Asystole 1 1
Gastrointestinal Hemorrhage 1 1
Cyst(s) 1 1
Abdominal Pain 1 1
Abscess 1 1
Anemia 1 1
Bradycardia 1 1
Bowel Burn 1 1
Pain 1 1
Muscle Spasm(s) 1 1
Myocardial Infarction 1 1
Necrosis 1 1
Shaking/Tremors 1 1
Abdominal Distention 1 1
Ulcer 1 1
Peritonitis 1 1
Shock 1 1
Swelling 1 1
Tachycardia 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Uterine Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 C.R. Bard, Inc. II Nov-16-2016
3 Gyrus Acmi, Incorporated II May-29-2018
4 Olympus Corporation of the Americas II Dec-15-2023
5 Olympus Corporation of the Americas II Aug-17-2023
6 Olympus Corporation of the Americas II Dec-14-2016
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