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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 1
DORNIER MEDTECH AMERICA INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 361 361
Detachment of Device or Device Component 123 123
Material Fragmentation 95 95
Fracture 83 83
Mechanical Problem 79 79
Sparking 53 53
Adverse Event Without Identified Device or Use Problem 38 38
Material Separation 33 33
Material Twisted/Bent 20 20
Crack 19 19
Thermal Decomposition of Device 16 16
Material Disintegration 15 15
Overheating of Device 15 15
Melted 14 14
Fire 12 12
Arcing 12 12
Defective Component 11 11
Material Deformation 10 10
Material Split, Cut or Torn 10 10
Insufficient Information 9 9
Component Missing 9 9
Arcing of Electrodes 7 7
Defective Device 7 7
Output Problem 6 6
Smoking 6 6
Use of Incorrect Control/Treatment Settings 5 5
Electrical /Electronic Property Problem 5 5
Material Integrity Problem 5 5
Improper or Incorrect Procedure or Method 5 5
Unintended Electrical Shock 5 5
Excessive Heating 5 5
Intermittent Loss of Power 4 4
No Apparent Adverse Event 4 4
Electrical Power Problem 4 4
Electrical Shorting 4 4
Device Damaged by Another Device 3 3
Failure to Cut 3 3
Disconnection 3 3
Explosion 3 3
Device Fell 2 2
Activation Failure 2 2
Appropriate Term/Code Not Available 2 2
Failure to Clean Adequately 2 2
Failure to Conduct 2 2
Material Rupture 2 2
Use of Device Problem 2 2
Dent in Material 2 2
Electro-Static Discharge 2 2
Fitting Problem 2 2
Connection Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 1 1
Packaging Problem 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Device Contamination with Chemical or Other Material 1 1
Device Dislodged or Dislocated 1 1
Electrical Overstress 1 1
Device Damaged Prior to Use 1 1
Failure to Deliver 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Failure to Align 1 1
Fumes or Vapors 1 1
Blocked Connection 1 1
Communication or Transmission Problem 1 1
Unraveled Material 1 1
Peeled/Delaminated 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Poor Quality Image 1 1
Energy Output Problem 1 1
Material Frayed 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Contamination 1 1
Circuit Failure 1 1
Device Alarm System 1 1
Loss of or Failure to Bond 1 1
Failure to Deliver Energy 1 1
Entrapment of Device 1 1
No Display/Image 1 1
Fluid/Blood Leak 1 1
Activation Problem 1 1
Device Handling Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 505 505
Insufficient Information 71 71
No Known Impact Or Consequence To Patient 66 66
Foreign Body In Patient 57 57
No Consequences Or Impact To Patient 39 39
Hemorrhage/Bleeding 20 20
Burn(s) 13 13
Internal Organ Perforation 8 8
Perforation 8 8
Device Embedded In Tissue or Plaque 8 8
Electric Shock 7 7
No Patient Involvement 5 5
Pancreatitis 4 4
No Information 3 3
Unspecified Infection 3 3
Rupture 3 3
Laceration(s) 3 3
No Code Available 3 3
Bowel Perforation 3 3
Urinary Incontinence 2 2
Death 2 2
Hematuria 2 2
Unspecified Gastrointestinal Problem 2 2
Blood Loss 2 2
Ecchymosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 1 1
Necrosis 1 1
Myocardial Infarction 1 1
Pain 1 1
Blister 1 1
Shaking/Tremors 1 1
Hyperextension 1 1
Abscess 1 1
Fever 1 1
Uterine Perforation 1 1
Gastrointestinal Hemorrhage 1 1
Bradycardia 1 1
Asystole 1 1
Skin Burning Sensation 1 1
Swelling 1 1
Cyst(s) 1 1
Full thickness (Third Degree) Burn 1 1
Tachycardia 1 1
Unspecified Kidney or Urinary Problem 1 1
Stenosis 1 1
Superficial (First Degree) Burn 1 1
Genital Bleeding 1 1
Anemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Olympus Corporation of the Americas II Dec-15-2023
3 Olympus Corporation of the Americas II Aug-17-2023
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