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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, surgical, disposable
Regulation Description Manual surgical instrument for general use.
Product CodeKDC
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 11 11
2017 9 9
2018 71 71
2019 16 16
2020 13 13
2021 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 66 66
Break 25 25
Material Separation 10 10
Defective Component 3 3
Detachment Of Device Component 2 2
Defective Device 2 2
Material Integrity Problem 2 2
Torn Material 2 2
Appropriate Term/Code Not Available 2 2
Migration 2 2
Use of Device Problem 2 2
Insufficient Information 1 1
Material Protrusion/Extrusion 1 1
Protective Measures Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Patient-Device Incompatibility 1 1
Connection Problem 1 1
Device Markings/Labelling Problem 1 1
Human Factors Issue 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Component Falling 1 1
Contamination 1 1
Crack 1 1
Migration or Expulsion of Device 1 1
Split 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 32 32
Pain 17 17
No Known Impact Or Consequence To Patient 16 16
No Consequences Or Impact To Patient 15 15
Blood Loss 13 13
Unspecified Infection 12 12
Post Operative Wound Infection 8 8
No Clinical Signs, Symptoms or Conditions 8 8
Urinary Tract Infection 7 7
Bacterial Infection 7 7
Erosion 7 7
Injury 6 6
No Code Available 5 5
Hemorrhage/Bleeding 5 5
Hematoma 4 4
Wound Dehiscence 4 4
Sepsis 4 4
No Patient Involvement 4 4
Foreign Body In Patient 3 3
Premature Labor 3 3
Obstruction/Occlusion 3 3
Inflammation 3 3
Laceration(s) 3 3
Abnormal Vaginal Discharge 3 3
Fistula 3 3
Fever 2 2
Micturition Urgency 2 2
Abdominal Pain 2 2
Calcium Deposits/Calcification 2 2
Seroma 2 2
Scar Tissue 2 2
Urinary Retention 2 2
Miscarriage 2 2
Insufficient Information 2 2
Urinary Frequency 2 2
Discomfort 2 2
Hernia 2 2
Therapeutic Response, Decreased 1 1
Rupture 1 1
Impaired Healing 1 1
Reaction 1 1
Hematuria 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Gastrointestinal Hemorrhage 1 1
Nausea 1 1
Necrosis 1 1
Septic Shock 1 1
Perforation 1 1
Skin Irritation 1 1
Swelling 1 1
Vomiting 1 1
Uterine Perforation 1 1
Cerebrospinal Fluid Leakage 1 1
Death 1 1
Purulent Discharge 1 1
Edema 1 1
Abscess 1 1
Adhesion(s) 1 1
Failure of Implant 1 1
Incontinence 1 1
Failure to Anastomose 1 1
Foreign Body Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon, Inc. II Sep-27-2016
2 Medical Action Industries, Inc. 306 II Jun-24-2021
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