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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
SYNAPTIC MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
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
83
83
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
529
529
Break
95
95
Insufficient Information
33
33
Activation, Positioning or Separation Problem
32
32
Difficult to Insert
28
28
Fracture
23
23
Material Separation
10
10
Detachment of Device or Device Component
10
10
Gas/Air Leak
10
10
Unintended Movement
9
9
Material Twisted/Bent
8
8
Detachment Of Device Component
7
7
Appropriate Term/Code Not Available
7
7
Device Contamination with Chemical or Other Material
6
6
Device Operates Differently Than Expected
5
5
Device Contamination with Body Fluid
5
5
Inflation Problem
5
5
Bent
5
5
Positioning Problem
5
5
Use of Device Problem
5
5
Contamination /Decontamination Problem
5
5
Physical Resistance/Sticking
4
4
Difficult to Advance
4
4
Material Fragmentation
4
4
Corroded
3
3
Improper or Incorrect Procedure or Method
3
3
No Apparent Adverse Event
3
3
Physical Resistance
3
3
Component Missing
3
3
Patient Device Interaction Problem
3
3
Difficult to Remove
3
3
Leak/Splash
3
3
Mechanical Problem
3
3
Scratched Material
2
2
Defective Device
2
2
Device Contaminated During Manufacture or Shipping
2
2
Material Puncture/Hole
2
2
Failure to Advance
2
2
Loose or Intermittent Connection
2
2
Entrapment of Device
2
2
Unexpected Therapeutic Results
2
2
Malposition of Device
2
2
Material Protrusion/Extrusion
2
2
Tear, Rip or Hole in Device Packaging
2
2
Loss of or Failure to Bond
1
1
Noise, Audible
1
1
Unintended Collision
1
1
Dull, Blunt
1
1
Device Inoperable
1
1
Compatibility Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Cardiac Perforation
425
425
No Clinical Signs, Symptoms or Conditions
100
100
No Known Impact Or Consequence To Patient
86
86
Pericardial Effusion
84
84
Low Blood Pressure/ Hypotension
43
43
Cardiac Tamponade
40
40
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
11
11
Hemorrhage/Bleeding
9
9
Thrombosis/Thrombus
8
8
Foreign Body In Patient
7
7
Air Embolism
6
6
Device Embedded In Tissue or Plaque
6
6
Arrhythmia
6
6
No Code Available
6
6
Vascular Dissection
6
6
Cardiac Arrest
6
6
Insufficient Information
5
5
No Information
5
5
Hematoma
4
4
Transient Ischemic Attack
4
4
Perforation of Vessels
3
3
Pseudoaneurysm
3
3
Chest Pain
3
3
Needle Stick/Puncture
3
3
Hemothorax
3
3
Thrombus
3
3
Patient Problem/Medical Problem
3
3
Aortic Dissection
2
2
Discomfort
2
2
Embolus
2
2
Pain
2
2
Non specific EKG/ECG Changes
2
2
Tachycardia
2
2
Extubate
1
1
Atrial Perforation
1
1
Unspecified Vascular Problem
1
1
Respiratory Failure
1
1
Hypoxia
1
1
ST Segment Elevation
1
1
Low Oxygen Saturation
1
1
Myocardial Infarction
1
1
Unspecified Tissue Injury
1
1
Pulmonary Edema
1
1
Fistula
1
1
Extravasation
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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