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TPLC
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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
23
23
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
292
292
Break
31
31
Difficult to Insert
28
28
Fracture
26
26
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
Physical Resistance/Sticking
5
5
Improper or Incorrect Procedure or Method
4
4
Difficult to Advance
4
4
Corroded
3
3
Positioning Problem
3
3
Patient Device Interaction Problem
3
3
No Apparent Adverse Event
3
3
Device Contaminated During Manufacture or Shipping
2
2
Difficult to Remove
2
2
Contamination /Decontamination Problem
2
2
Material Protrusion/Extrusion
2
2
Component Missing
2
2
Obstruction of Flow
2
2
Device Contamination with Chemical or Other Material
2
2
Device Damaged by Another Device
2
2
Noise, Audible
1
1
Dull, Blunt
1
1
Failure to Disconnect
1
1
Appropriate Term/Code Not Available
1
1
Failure to Advance
1
1
Component Misassembled
1
1
Inadequacy of Device Shape and/or Size
1
1
Structural Problem
1
1
Particulates
1
1
Use of Device Problem
1
1
Material Fragmentation
1
1
Scratched Material
1
1
Contamination
1
1
Defective Device
1
1
Material Puncture/Hole
1
1
Malposition of Device
1
1
Off-Label Use
1
1
Entrapment of Device
1
1
Compatibility Problem
1
1
Device-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Cardiac Perforation
233
233
No Clinical Signs, Symptoms or Conditions
109
109
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
9
9
Hemorrhage/Bleeding
8
8
Arrhythmia
6
6
Stroke/CVA
6
6
Death
6
6
Foreign Body In Patient
6
6
Perforation
6
6
Insufficient Information
5
5
Pseudoaneurysm
4
4
Needle Stick/Puncture
4
4
Transient Ischemic Attack
4
4
Hematoma
4
4
Vascular Dissection
4
4
Air Embolism
3
3
Non specific EKG/ECG Changes
2
2
Thrombus
2
2
Cardiac Arrest
1
1
Edema
1
1
Ventricular Fibrillation
1
1
Atrial Fibrillation
1
1
Embolism/Embolus
1
1
Unspecified Mental, Emotional or Behavioural Problem
1
1
Chest Pain
1
1
Foreign Body Embolism
1
1
No Code Available
1
1
Pain
1
1
Scar Tissue
1
1
Bradycardia
1
1
Asystole
1
1
Heart Failure/Congestive Heart Failure
1
1
Perforation of Vessels
1
1
Unspecified Tissue Injury
1
1
Hypoxia
1
1
Myocardial Infarction
1
1
Pneumothorax
1
1
Hypersensitivity/Allergic reaction
1
1
Superficial (First Degree) Burn
1
1
Atrial Perforation
1
1
Unspecified Vascular Problem
1
1
Hemothorax
1
1
ST Segment Elevation
1
1
Low Oxygen Saturation
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
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