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TPLC
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show TPLC since
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2024
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Device
coagulator, laparoscopic, unipolar (and accessories)
Product Code
HFG
Regulation Number
884.4160
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
75
75
Use of Device Problem
8
8
Material Separation
7
7
Insufficient Information
3
3
Scratched Material
2
2
Detachment of Device or Device Component
2
2
No Display/Image
2
2
Material Fragmentation
2
2
Break
2
2
Thermal Decomposition of Device
1
1
Detachment Of Device Component
1
1
Component Incompatible
1
1
Melted
1
1
Accessory Incompatible
1
1
Device Operates Differently Than Expected
1
1
Malposition of Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
Appropriate Term/Code Not Available
1
1
Material Split, Cut or Torn
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
Bowel Burn
10
10
Abdominal Pain
9
9
Bacterial Infection
9
9
Fever
8
8
Burn(s)
5
5
Abscess
5
5
Pain
5
5
Bowel Perforation
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Uterine Perforation
4
4
Unspecified Infection
4
4
Nausea
3
3
Necrosis
3
3
Hemorrhage/Bleeding
3
3
Rupture
3
3
Device Embedded In Tissue or Plaque
2
2
Vomiting
2
2
No Consequences Or Impact To Patient
2
2
Organ Dehiscence
2
2
Pelvic Inflammatory Disease
2
2
Sepsis
2
2
Insufficient Information
2
2
Urinary Tract Infection
1
1
Scar Tissue
1
1
Nerve Damage
1
1
Oversedation
1
1
Bradycardia
1
1
Diarrhea
1
1
Fistula
1
1
Hematoma
1
1
Burn, Thermal
1
1
Weight Changes
1
1
Hypervolemia
1
1
Abnormal Vaginal Discharge
1
1
Vesicovaginal Fistula
1
1
Sexually Transmitted Infection
1
1
Unspecified Tissue Injury
1
1
Injury
1
1
Needle Stick/Puncture
1
1
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