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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


Premarket Reviews
ManufacturerDecision
ACESSA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HALT MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
HALT MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
MCGAN TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3 3
2015 2 2
2016 5 5
2017 2 2
2018 3 3
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 78 78
Use of Device Problem 8 8
Material Separation 7 7
Insufficient Information 3 3
Material Fragmentation 3 3
Detachment of Device or Device Component 3 3
Break 2 2
No Display/Image 2 2
Scratched Material 2 2
Material Split, Cut or Torn 1 1
Malposition of Device 1 1
Accessory Incompatible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Thermal Decomposition of Device 1 1
Device Operates Differently Than Expected 1 1
Appropriate Term/Code Not Available 1 1
Melted 1 1
Component Incompatible 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
No Known Impact Or Consequence To Patient 12 12
Abdominal Pain 10 10
Bowel Burn 10 10
Fever 10 10
Bacterial Infection 9 9
Bowel Perforation 6 6
Abscess 6 6
Pain 6 6
Uterine Perforation 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Burn(s) 5 5
Unspecified Infection 4 4
Nausea 3 3
Sepsis 3 3
Necrosis 3 3
Hemorrhage/Bleeding 3 3
Rupture 3 3
Insufficient Information 3 3
Device Embedded In Tissue or Plaque 2 2
No Consequences Or Impact To Patient 2 2
Organ Dehiscence 2 2
Vomiting 2 2
Pelvic Inflammatory Disease 2 2
Hematoma 2 2
Diarrhea 1 1
Nerve Damage 1 1
Septic Shock 1 1
Foreign Body In Patient 1 1
Needle Stick/Puncture 1 1
Injury 1 1
Scar Tissue 1 1
Vesicovaginal Fistula 1 1
Oversedation 1 1
Bradycardia 1 1
Sexually Transmitted Infection 1 1
Unspecified Tissue Injury 1 1
Burn, Thermal 1 1
Abnormal Vaginal Discharge 1 1
Fistula 1 1
Urinary Tract Infection 1 1
Hypervolemia 1 1
Weight Changes 1 1

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