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TPLC
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Device
instrument, ligature passing and knot tying
Regulation Description
Manual surgical instrument for general use.
Product Code
HCF
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
27
27
2021
46
46
2022
68
68
2023
57
57
2024
124
124
2025
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
97
97
Material Deformation
59
59
Difficult to Advance
15
15
Detachment of Device or Device Component
15
15
Device-Device Incompatibility
13
13
Use of Device Problem
12
12
Misfire
11
11
Unintended Movement
9
9
Insufficient Information
7
7
Failure to Cut
6
6
Mechanical Jam
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Mechanical Problem
4
4
Crack
4
4
Defective Device
4
4
Failure to Fire
3
3
Difficult to Open or Close
3
3
Material Twisted/Bent
3
3
Packaging Problem
3
3
Physical Resistance/Sticking
3
3
Device Damaged Prior to Use
2
2
Defective Component
2
2
Appropriate Term/Code Not Available
2
2
Entrapment of Device
2
2
Output Problem
2
2
Material Split, Cut or Torn
2
2
Positioning Failure
1
1
Failure to Disconnect
1
1
Device Contaminated During Manufacture or Shipping
1
1
Activation, Positioning or Separation Problem
1
1
Device Damaged by Another Device
1
1
Difficult to Insert
1
1
Migration
1
1
No Apparent Adverse Event
1
1
Material Disintegration
1
1
Malposition of Device
1
1
Failure to Advance
1
1
Activation Problem
1
1
Loose or Intermittent Connection
1
1
Flushing Problem
1
1
Difficult or Delayed Activation
1
1
Component Missing
1
1
Firing Problem
1
1
Difficult or Delayed Positioning
1
1
Connection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
262
262
Insufficient Information
26
26
No Consequences Or Impact To Patient
10
10
Foreign Body In Patient
8
8
Aortic Valve Insufficiency/ Regurgitation
5
5
No Known Impact Or Consequence To Patient
4
4
Not Applicable
3
3
Pericardial Effusion
2
2
Valvular Insufficiency/ Regurgitation
2
2
Mitral Valve Insufficiency/ Regurgitation
2
2
Ischemic Heart Disease
2
2
Laceration(s)
2
2
Chest Pain
2
2
Unspecified Tissue Injury
2
2
Cusp Tear
1
1
Tissue Breakdown
1
1
Vascular Dissection
1
1
Syncope/Fainting
1
1
Foreign Body Embolism
1
1
Cardiac Perforation
1
1
Aortic Regurgitation
1
1
Atrial Fibrillation
1
1
Death
1
1
Endocarditis
1
1
Hemorrhage/Bleeding
1
1
Unspecified Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Inc
II
Jan-31-2024
2
New Wave Endo-Surgical, Corp.
II
May-09-2023
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