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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
Regulation Description Manual surgical instrument for general use.
Product CodeHCF
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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