Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
electrode, electrosurgical, active, urological
Product Code
FAS
Regulation Number
876.4300
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
1. K100275
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PL
...
2. K102781
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION
...
3. K120418
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRO
...
4. K152092
Resection Electrodes
5. K171965
Resection Electrodes with HF cable
6. K210651
Resection Electrodes with HF cable
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
-
-