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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, ligature passing and knot tying
Product CodeHCF
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 40 40
2020 27 27
2021 46 46
2022 68 68
2023 57 57
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 93 93
Material Deformation 35 35
Detachment of Device or Device Component 14 14
Difficult to Advance 14 14
Misfire 13 13
Use of Device Problem 12 12
Device-Device Incompatibility 10 10
Insufficient Information 8 8
Unintended Movement 7 7
Material Twisted/Bent 7 7
Failure to Cut 6 6
Mechanical Jam 5 5
Difficult to Open or Close 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Defective Device 4 4
Failure to Fire 4 4
Mechanical Problem 4 4
Crack 4 4
Physical Resistance/Sticking 4 4
Packaging Problem 3 3
Fracture 3 3
Entrapment of Device 2 2
Defective Component 2 2
Loose or Intermittent Connection 2 2
Activation, Positioning or Separation Problem 2 2
Output Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Split, Cut or Torn 2 2
Firing Problem 1 1
No Apparent Adverse Event 1 1
Activation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Damaged by Another Device 1 1
Component Missing 1 1
Failure to Advance 1 1
Malposition of Device 1 1
Connection Problem 1 1
Flushing Problem 1 1
Difficult to Insert 1 1
Positioning Failure 1 1
Material Disintegration 1 1
Difficult to Remove 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 173 173
No Consequences Or Impact To Patient 36 36
Insufficient Information 20 20
No Known Impact Or Consequence To Patient 9 9
Foreign Body In Patient 7 7
Not Applicable 7 7
Aortic Valve Insufficiency/ Regurgitation 5 5
Mitral Valve Insufficiency/ Regurgitation 2 2
Unspecified Tissue Injury 2 2
Pericardial Effusion 2 2
Valvular Insufficiency/ Regurgitation 2 2
Laceration(s) 2 2
Cardiac Perforation 2 2
No Patient Involvement 2 2
Chest Pain 2 2
Death 1 1
Endocarditis 1 1
Unspecified Infection 1 1
Injury 1 1
Ischemic Heart Disease 1 1
Aortic Regurgitation 1 1
Atrial Fibrillation 1 1
Cusp Tear 1 1
Tissue Breakdown 1 1
Vascular Dissection 1 1
Syncope/Fainting 1 1
No Code Available 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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