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TPLC
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Device
system, ablation, microwave and accessories
Product Code
NEY
Regulation Number
878.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS, INC.
SUBSTANTIALLY EQUIVALENT
4
BETTERS (SUZHOU)MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
BETTERS(SUZHOU) MEDICAL CO., LTD
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN LLC
SUBSTANTIALLY EQUIVALENT
2
COVIDIEN, LLC
SUBSTANTIALLY EQUIVALENT
1
CREO MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
4
EMBLATION LIMITED
SUBSTANTIALLY EQUIVALENT
1
EMBLATION LTD.
SUBSTANTIALLY EQUIVALENT
1
GALIL MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
HYGEA MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC
SUBSTANTIALLY EQUIVALENT
1
MEDWAVES, INC.
SUBSTANTIALLY EQUIVALENT
1
MIMA-PRO SCIENTIFIC INC.
SUBSTANTIALLY EQUIVALENT
1
NANJING ECO MICROWAVE SYSTEM CO., LTD
SUBSTANTIALLY EQUIVALENT
1
NANJING ECO MICROWAVE SYSTEM CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NEUWAVE MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
NEUWAVE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
123
123
2020
128
128
2021
217
217
2022
142
142
2023
107
107
2024
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
251
251
Detachment of Device or Device Component
135
135
Appropriate Term/Code Not Available
117
117
Break
98
98
Temperature Problem
51
51
Leak/Splash
22
22
Device Alarm System
19
19
No Flow
19
19
Energy Output Problem
14
14
Fracture
13
13
Material Twisted/Bent
13
13
Activation Problem
13
13
Insufficient Information
13
13
Device Displays Incorrect Message
12
12
Failure to Fire
9
9
Activation, Positioning or Separation Problem
9
9
Use of Device Problem
9
9
Gas/Air Leak
8
8
Connection Problem
6
6
Therapeutic or Diagnostic Output Failure
6
6
Difficult or Delayed Activation
5
5
Defective Device
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Material Separation
5
5
Material Fragmentation
5
5
Thermal Decomposition of Device
5
5
Intermittent Energy Output
5
5
Computer Software Problem
4
4
Entrapment of Device
4
4
Difficult to Remove
4
4
Peeled/Delaminated
4
4
Visual Prompts will not Clear
3
3
Failure to Deliver Energy
3
3
Fluid/Blood Leak
3
3
Insufficient Heating
3
3
Material Discolored
3
3
Material Integrity Problem
3
3
Biocompatibility
3
3
Output Problem
3
3
Protective Measures Problem
3
3
Excessive Heating
3
3
Pumping Problem
2
2
Firing Problem
2
2
Delivered as Unsterile Product
2
2
Failure to Shut Off
2
2
No Display/Image
2
2
Continuous Firing
2
2
Crack
2
2
Melted
2
2
Flaked
2
2
Component Missing
2
2
Failure to Read Input Signal
2
2
Improper or Incorrect Procedure or Method
2
2
Dull, Blunt
1
1
Misfire
1
1
Device Damaged Prior to Use
1
1
Pitted
1
1
Failure to Power Up
1
1
Device Difficult to Setup or Prepare
1
1
Therapy Delivered to Incorrect Body Area
1
1
Device Remains Activated
1
1
Self-Activation or Keying
1
1
Output above Specifications
1
1
Overheating of Device
1
1
Poor Quality Image
1
1
Display or Visual Feedback Problem
1
1
Loss of or Failure to Bond
1
1
Device Markings/Labelling Problem
1
1
Device Dislodged or Dislocated
1
1
Human-Device Interface Problem
1
1
Communication or Transmission Problem
1
1
Computer Operating System Problem
1
1
Patient-Device Incompatibility
1
1
Unexpected Shutdown
1
1
No Apparent Adverse Event
1
1
Wireless Communication Problem
1
1
Patient Device Interaction Problem
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Scratched Material
1
1
Power Problem
1
1
Output below Specifications
1
1
Misassembly During Maintenance/Repair
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
198
198
Device Embedded In Tissue or Plaque
94
94
No Code Available
61
62
Insufficient Information
61
61
No Consequences Or Impact To Patient
59
59
Foreign Body In Patient
56
56
Pneumothorax
50
50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
49
49
Hemorrhage/Bleeding
35
35
Pain
31
31
Pleural Effusion
26
26
Abscess
26
26
Hematoma
25
25
Burn(s)
21
22
Radiation Exposure, Unintended
16
16
No Known Impact Or Consequence To Patient
14
14
Unspecified Tissue Injury
14
14
Obstruction/Occlusion
13
13
Abdominal Pain
12
12
Fistula
11
11
High Blood Pressure/ Hypertension
10
10
Thrombosis/Thrombus
10
10
Unspecified Infection
9
10
Hypersensitivity/Allergic reaction
8
8
Chest Pain
8
8
Full thickness (Third Degree) Burn
8
8
Blood Loss
7
7
Unintended Radiation Exposure
7
7
Death
7
7
Fever
7
7
Bacterial Infection
6
6
Injury
6
6
Pneumonia
6
6
No Information
6
6
Embolism/Embolus
5
5
Cancer
5
5
Nausea
5
5
Urinary Tract Infection
5
5
Peritonitis
4
4
Nerve Damage
4
4
Thrombosis
4
4
Hemoptysis
4
4
Embolism
4
4
Unspecified Hepatic or Biliary Problem
4
4
Hematuria
4
4
No Patient Involvement
4
4
Bowel Perforation
4
4
Patient Problem/Medical Problem
3
3
Aspiration Pneumonitis
3
3
Hemothorax
3
3
Renal Failure
3
3
Sepsis
3
3
Necrosis
3
3
Vomiting
3
3
Burn, Thermal
3
3
Hypoesthesia
2
2
Post Operative Wound Infection
2
2
Urinary Retention
2
2
Chronic Obstructive Pulmonary Disease (COPD)
2
2
Internal Organ Perforation
2
2
Laceration(s)
2
2
Tachycardia
2
2
Fatigue
2
2
Bone Fracture(s)
2
2
Low Blood Pressure/ Hypotension
2
2
Awareness during Anaesthesia
2
2
Pulmonary Embolism
2
2
Bradycardia
2
2
Intra-Abdominal Hemorrhage
2
2
Pseudoaneurysm
2
2
Swelling/ Edema
2
2
Ascites
1
1
Tissue Breakdown
1
1
Superficial (First Degree) Burn
1
1
Partial thickness (Second Degree) Burn
1
1
Vascular Dissection
1
1
Retroperitoneal Hemorrhage
1
1
Cough
1
1
Muscle/Tendon Damage
1
1
Blister
1
1
Cancer Cells Dissemination
1
1
Nodule
1
1
Pericardial Effusion
1
1
Syncope/Fainting
1
1
Heart Block
1
1
Dyspnea
1
1
Cardiac Arrest
1
1
Cardiomyopathy
1
1
Cardiopulmonary Arrest
1
1
Wound Dehiscence
1
1
Air Embolism
1
1
Aspiration/Inhalation
1
1
Biliary Cirrhosis
1
1
Hypovolemic Shock
1
1
Ischemia
1
1
Hepatitis
1
1
Hyperemia
1
1
Tissue Damage
1
1
Ulceration
1
1
Septic Shock
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics Inc. (Navilyst Medical Inc.)
II
May-31-2019
2
Angiodynamics, Inc.
II
Sep-08-2021
3
Covidien Llc
II
Nov-05-2021
4
Covidien, LLC
II
Jan-12-2023
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