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TPLC
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show TPLC since
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2024
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Device
trocar
Product Code
DRC
Regulation Number
870.1390
Device Class
2
Premarket Reviews
Manufacturer
Decision
GREATBATCH MEDICAL
SUBSTANTIALLY EQUIVALENT
2
OSCOR INC.
SUBSTANTIALLY EQUIVALENT
1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
5
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
SUBSTANTIALLY EQUIVALENT
2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
1. K122587
BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 40720
...
SYNAPTIC MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
63
63
2015
51
51
2016
62
62
2017
70
70
2018
85
85
2019
95
95
2020
108
108
2021
78
78
2022
61
61
2023
109
109
2024
36
36
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
513
513
Break
94
94
Insufficient Information
33
33
Activation, Positioning or Separation Problem
32
32
Difficult to Insert
24
24
Fracture
16
16
Detachment of Device or Device Component
10
10
Gas/Air Leak
10
10
Unintended Movement
9
9
Material Separation
8
8
Detachment Of Device Component
7
7
Appropriate Term/Code Not Available
7
7
Device Contamination with Chemical or Other Material
6
6
Contamination /Decontamination Problem
5
5
Positioning Problem
5
5
Device Operates Differently Than Expected
5
5
Inflation Problem
5
5
Bent
5
5
Use of Device Problem
5
5
Material Fragmentation
4
4
Difficult to Advance
4
4
Physical Resistance/Sticking
4
4
Material Twisted/Bent
3
3
Component Missing
3
3
Device Contamination with Body Fluid
3
3
Physical Resistance
3
3
No Apparent Adverse Event
3
3
Patient Device Interaction Problem
3
3
Corroded
3
3
Difficult to Remove
3
3
Leak/Splash
3
3
Mechanical Problem
3
3
Loose or Intermittent Connection
2
2
Improper or Incorrect Procedure or Method
2
2
Unexpected Therapeutic Results
2
2
Entrapment of Device
2
2
Scratched Material
2
2
Device Contaminated During Manufacture or Shipping
2
2
Material Protrusion/Extrusion
2
2
Defective Device
2
2
Failure to Advance
2
2
Tear, Rip or Hole in Device Packaging
2
2
Malposition of Device
2
2
Extrusion
1
1
Device-Device Incompatibility
1
1
Dull, Blunt
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Expiration Date Error
1
1
Failure to Disconnect
1
1
Device Or Device Fragments Location Unknown
1
1
Packaging Problem
1
1
Compatibility Problem
1
1
Component Misassembled
1
1
Noise, Audible
1
1
Flaked
1
1
Crack
1
1
Deflation Problem
1
1
Positioning Failure
1
1
Partial Blockage
1
1
Loss of or Failure to Bond
1
1
Air Leak
1
1
Failure To Adhere Or Bond
1
1
Contamination
1
1
Burst Container or Vessel
1
1
Complete Blockage
1
1
Device Inoperable
1
1
Device Damaged Prior to Use
1
1
Material Rupture
1
1
Inadequacy of Device Shape and/or Size
1
1
Kinked
1
1
Migration or Expulsion of Device
1
1
Poor Quality Image
1
1
Delivered as Unsterile Product
1
1
Unintended Collision
1
1
Particulates
1
1
Material Puncture/Hole
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Cardiac Perforation
412
412
No Known Impact Or Consequence To Patient
86
86
Pericardial Effusion
83
83
No Clinical Signs, Symptoms or Conditions
78
78
Low Blood Pressure/ Hypotension
41
41
Cardiac Tamponade
36
36
No Consequences Or Impact To Patient
32
32
Death
24
24
Perforation
16
16
Stroke/CVA
15
15
No Patient Involvement
14
14
Great Vessel Perforation
10
10
Hemorrhage/Bleeding
8
8
Thrombosis/Thrombus
7
7
Foreign Body In Patient
7
7
No Code Available
6
6
Device Embedded In Tissue or Plaque
6
6
Cardiac Arrest
6
6
Arrhythmia
5
5
No Information
5
5
Insufficient Information
5
5
Vascular Dissection
5
5
Air Embolism
4
4
Transient Ischemic Attack
4
4
Thrombus
3
3
Perforation of Vessels
3
3
Hemothorax
3
3
Chest Pain
3
3
Hematoma
3
3
Patient Problem/Medical Problem
3
3
Pseudoaneurysm
3
3
Needle Stick/Puncture
3
3
Aortic Dissection
2
2
Embolus
2
2
Pain
2
2
Tachycardia
2
2
Discomfort
2
2
Complaint, Ill-Defined
1
1
Injury
1
1
Extubate
1
1
Diaphoresis
1
1
Ventricular Fibrillation
1
1
Hypersensitivity/Allergic reaction
1
1
Pneumothorax
1
1
Pulmonary Edema
1
1
ST Segment Elevation
1
1
Extravasation
1
1
Fistula
1
1
Hypoxia
1
1
Myocardial Infarction
1
1
Neuropathy
1
1
Occlusion
1
1
Non specific EKG/ECG Changes
1
1
Edema
1
1
Anaphylactic Shock
1
1
Atrial Fibrillation
1
1
Bradycardia
1
1
Sudden Cardiac Death
1
1
Atrial Perforation
1
1
Blood Loss
1
1
Low Oxygen Saturation
1
1
Respiratory Failure
1
1
Rupture
1
1
Complete Heart Block
1
1
Superficial (First Degree) Burn
1
1
Foreign Body Embolism
1
1
Unspecified Vascular Problem
1
1
Asystole
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Nov-13-2021
2
Cook Inc.
I
Mar-13-2019
3
Cook Incorporated
II
Apr-12-2024
4
CooperSurgical, Inc.
II
May-01-2018
5
CooperSurgical, Inc. D.B.A. Lone Star Medical Products
II
Oct-29-2014
6
Ethicon Endo-Surgery Inc
II
Jun-26-2015
7
Instrumed International, Inc.
II
Dec-16-2014
8
Medical Device Technologies, Inc.
II
Jul-13-2010
9
Merit Medical Systems, Inc.
II
Mar-16-2021
10
Merit Medical Systems, Inc.
II
Apr-12-2016
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