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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coagulator, laparoscopic, unipolar (and accessories)
Product CodeHFG
Regulation Number 884.4160
Device Class 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 6 6
2021 20 20
2022 20 20
2023 36 36
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 76 76
Use of Device Problem 8 8
Detachment of Device or Device Component 3 3
Scratched Material 2 2
Material Separation 1 1
Material Fragmentation 1 1
Appropriate Term/Code Not Available 1 1
Component Incompatible 1 1
Material Split, Cut or Torn 1 1
Break 1 1
No Display/Image 1 1
Accessory Incompatible 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Abdominal Pain 10 10
Bowel Burn 10 10
Bacterial Infection 9 9
Fever 8 8
Bowel Perforation 6 6
Pain 6 6
Abscess 6 6
Uterine Perforation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Unspecified Infection 4 4
Burn(s) 4 4
Nausea 3 3
Sepsis 3 3
Necrosis 3 3
Rupture 3 3
Insufficient Information 3 3
Hemorrhage/Bleeding 3 3
Hematoma 2 2
Pelvic Inflammatory Disease 2 2
No Known Impact Or Consequence To Patient 2 2
Vomiting 2 2
Organ Dehiscence 2 2
No Consequences Or Impact To Patient 2 2
Weight Changes 1 1
Abnormal Vaginal Discharge 1 1
Oversedation 1 1
Needle Stick/Puncture 1 1
Foreign Body In Patient 1 1
Diarrhea 1 1
Nerve Damage 1 1
Septic Shock 1 1
Scar Tissue 1 1
Vesicovaginal Fistula 1 1
Bradycardia 1 1
Sexually Transmitted Infection 1 1
Unspecified Tissue Injury 1 1
Fistula 1 1
Urinary Tract Infection 1 1
Hypervolemia 1 1

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