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TPLC
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show TPLC since
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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
1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL
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
60
60
2023
109
109
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
500
500
Break
93
93
Insufficient Information
33
33
Activation, Positioning or Separation Problem
32
32
Difficult to Insert
20
20
Fracture
13
13
Detachment of Device or Device Component
10
10
Unintended Movement
9
9
Gas/Air Leak
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
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
398
398
No Known Impact Or Consequence To Patient
86
86
Pericardial Effusion
81
81
No Clinical Signs, Symptoms or Conditions
72
72
Low Blood Pressure/ Hypotension
41
41
Cardiac Tamponade
36
36
No Consequences Or Impact To Patient
32
32
Death
24
24
Stroke/CVA
15
15
Perforation
15
15
No Patient Involvement
14
14
Great Vessel Perforation
9
9
Hemorrhage/Bleeding
8
8
Foreign Body In Patient
7
7
No Code Available
6
6
Device Embedded In Tissue or Plaque
6
6
Cardiac Arrest
6
6
Insufficient Information
5
5
No Information
5
5
Arrhythmia
5
5
Vascular Dissection
5
5
Transient Ischemic Attack
4
4
Air Embolism
4
4
Thrombus
3
3
Chest Pain
3
3
Hematoma
3
3
Patient Problem/Medical Problem
3
3
Pseudoaneurysm
3
3
Perforation of Vessels
3
3
Hemothorax
3
3
Thrombosis/Thrombus
3
3
Aortic Dissection
2
2
Tachycardia
2
2
Pain
2
2
Embolus
2
2
Needle Stick/Puncture
2
2
Discomfort
2
2
Pneumothorax
1
1
Injury
1
1
Atrial Fibrillation
1
1
Ventricular Fibrillation
1
1
Fistula
1
1
Blood Loss
1
1
Unspecified Vascular Problem
1
1
Rupture
1
1
Neuropathy
1
1
Pulmonary Edema
1
1
Myocardial Infarction
1
1
Edema
1
1
Anaphylactic Shock
1
1
Hypoxia
1
1
Hypersensitivity/Allergic reaction
1
1
Atrial Perforation
1
1
Low Oxygen Saturation
1
1
Respiratory Failure
1
1
Diaphoresis
1
1
Occlusion
1
1
Complaint, Ill-Defined
1
1
Foreign Body Embolism
1
1
Sudden Cardiac Death
1
1
Superficial (First Degree) Burn
1
1
Extravasation
1
1
Non specific EKG/ECG Changes
1
1
Extubate
1
1
ST Segment Elevation
1
1
Complete Heart Block
1
1
Unspecified Tissue Injury
1
1
Bradycardia
1
1
Asystole
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Nov-13-2021
2
Cook Inc.
I
Mar-13-2019
3
CooperSurgical, Inc.
II
May-01-2018
4
CooperSurgical, Inc. D.B.A. Lone Star Medical Products
II
Oct-29-2014
5
Ethicon Endo-Surgery Inc
II
Jun-26-2015
6
Instrumed International, Inc.
II
Dec-16-2014
7
Medical Device Technologies, Inc.
II
Jul-13-2010
8
Merit Medical Systems, Inc.
II
Mar-16-2021
9
Merit Medical Systems, Inc.
II
Apr-12-2016
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