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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
trocar
Regulation Description
Trocar.
Product Code
DRC
Regulation Number
870.1390
Device Class
2
Premarket Reviews
Manufacturer
Decision
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING LLC.
SUBSTANTIALLY EQUIVALENT
2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SYNAPTIC MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
108
108
2021
78
78
2022
61
61
2023
109
109
2024
105
105
2025
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
277
277
Break
31
31
Difficult to Insert
28
28
Fracture
23
23
Insufficient Information
11
11
Gas/Air Leak
11
11
Unintended Movement
9
9
Material Twisted/Bent
9
9
Detachment of Device or Device Component
7
7
Material Separation
7
7
Device Contamination with Body Fluid
6
6
Difficult to Advance
4
4
Improper or Incorrect Procedure or Method
4
4
Positioning Problem
3
3
Patient Device Interaction Problem
3
3
Physical Resistance/Sticking
3
3
Corroded
3
3
Component Missing
2
2
Difficult to Remove
2
2
Contamination /Decontamination Problem
2
2
Device Contamination with Chemical or Other Material
2
2
No Apparent Adverse Event
2
2
Material Protrusion/Extrusion
2
2
Obstruction of Flow
2
2
Device Contaminated During Manufacture or Shipping
2
2
Entrapment of Device
1
1
Off-Label Use
1
1
Material Puncture/Hole
1
1
Contamination
1
1
Failure to Disconnect
1
1
Material Fragmentation
1
1
Use of Device Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Scratched Material
1
1
Compatibility Problem
1
1
Defective Device
1
1
Device-Device Incompatibility
1
1
Malposition of Device
1
1
Failure to Advance
1
1
Structural Problem
1
1
Component Misassembled
1
1
Noise, Audible
1
1
Dull, Blunt
1
1
Particulates
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Cardiac Perforation
222
222
No Clinical Signs, Symptoms or Conditions
104
104
Pericardial Effusion
41
41
Cardiac Tamponade
28
28
Low Blood Pressure/ Hypotension
19
19
No Consequences Or Impact To Patient
14
14
No Known Impact Or Consequence To Patient
13
13
Thrombosis/Thrombus
10
10
Great Vessel Perforation
8
8
Hemorrhage/Bleeding
7
7
Foreign Body In Patient
6
6
Perforation
6
6
Death
6
6
Stroke/CVA
6
6
Insufficient Information
5
5
Arrhythmia
5
5
Transient Ischemic Attack
4
4
Hematoma
4
4
Vascular Dissection
4
4
Air Embolism
3
3
Needle Stick/Puncture
3
3
Pseudoaneurysm
3
3
Non specific EKG/ECG Changes
2
2
Thrombus
2
2
Bradycardia
1
1
Cardiac Arrest
1
1
Atrial Fibrillation
1
1
Chest Pain
1
1
Edema
1
1
Fistula
1
1
Heart Failure/Congestive Heart Failure
1
1
Asystole
1
1
Hemothorax
1
1
Hypersensitivity/Allergic reaction
1
1
Unspecified Vascular Problem
1
1
Hypoxia
1
1
Unspecified Tissue Injury
1
1
Foreign Body Embolism
1
1
Embolism/Embolus
1
1
Myocardial Infarction
1
1
Pain
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Pneumothorax
1
1
ST Segment Elevation
1
1
Scar Tissue
1
1
No Code Available
1
1
Ventricular Fibrillation
1
1
Perforation of Vessels
1
1
Device Embedded In Tissue or Plaque
1
1
Superficial (First Degree) Burn
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Nov-13-2021
2
Cook Incorporated
II
Apr-12-2024
3
Merit Medical Systems, Inc.
II
Mar-16-2021
-
-