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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
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
Material Fragmentation
3
3
Insufficient Information
3
3
Detachment of Device or Device Component
3
3
Break
2
2
No Display/Image
2
2
Scratched Material
2
2
Device Operates Differently Than Expected
1
1
Appropriate Term/Code Not Available
1
1
Material Split, Cut or Torn
1
1
Malposition of Device
1
1
Accessory Incompatible
1
1
Thermal Decomposition of Device
1
1
Melted
1
1
Component Incompatible
1
1
Detachment Of Device Component
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
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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