Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Break 641 641
Material Fragmentation 131 131
Detachment of Device or Device Component 126 126
Fracture 114 114
Mechanical Problem 106 106
Sparking 71 71
Detachment Of Device Component 55 55
Adverse Event Without Identified Device or Use Problem 47 47
Material Separation 39 39
Component Falling 30 30
Thermal Decomposition of Device 23 23
Melted 23 23
Crack 20 20
Material Twisted/Bent 18 18
Overheating of Device 17 17
Material Disintegration 16 16
Fire 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
Electrical Shorting 8 8
Smoking 8 8
Charred 8 8
Improper or Incorrect Procedure or Method 7 7
Defective Device 7 7
Output Problem 7 7
Device Operates Differently Than Expected 6 6
Material Integrity Problem 6 6
Failure to Cut 6 6
Electrical /Electronic Property Problem 6 6
Use of Incorrect Control/Treatment Settings 5 5
Unintended Electrical Shock 5 5
Excessive Heating 5 5
Intermittent Loss of Power 4 4
Device Contamination with Chemical or Other Material 4 4
Device Damaged by Another Device 4 4
Electrical Power Problem 4 4
No Apparent Adverse Event 4 4
Peeled/Delaminated 4 4
Product Quality Problem 3 3
Connection Problem 3 3
Nonstandard Device 3 3
Bent 3 3
Disconnection 3 3
Explosion 3 3
Device Fell 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
Failure to Clean Adequately 2 2
Failure to Conduct 2 2
Failure to Deliver Energy 2 2
Flaked 2 2
Use of Device Problem 2 2
Dent in Material 2 2
Electro-Static Discharge 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 2 2
Device Inoperable 2 2
Unraveled Material 1 1
Difficult to Remove 1 1
Material Rupture 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Slipped 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Off-Label Use 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
Communication or Transmission Problem 1 1
Fluid/Blood Leak 1 1
Entrapment of Device 1 1
Material Frayed 1 1
Hole In Material 1 1
Difficult to Insert 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Energy Output Problem 1 1
Misassembled 1 1
Poor Quality Image 1 1
Contamination 1 1
No Display/Image 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 488 488
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 69 69
Device Embedded In Tissue or Plaque 23 23
Hemorrhage/Bleeding 20 20
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
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
-
-