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TPLC
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Device
endoscopic suture/plication system, gastroesophageal reflux disease (gerd)
Definition
To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.
Product Code
ODE
Regulation Number
876.1500
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
10
10
2020
18
18
2021
24
24
2022
16
16
2023
28
28
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
52
52
Insufficient Information
14
14
Detachment of Device or Device Component
7
7
Use of Device Problem
6
6
Improper or Incorrect Procedure or Method
5
5
Failure to Fire
5
5
Loss of or Failure to Bond
4
4
Therapeutic or Diagnostic Output Failure
4
4
Mechanical Problem
3
3
Break
3
3
Physical Resistance/Sticking
3
3
Material Deformation
2
2
Mechanical Jam
2
2
No Apparent Adverse Event
2
2
Misfire
2
2
Difficult to Remove
2
2
Patient-Device Incompatibility
1
1
Material Twisted/Bent
1
1
Migration
1
1
Device Fell
1
1
Obstruction of Flow
1
1
Retraction Problem
1
1
Appropriate Term/Code Not Available
1
1
Material Separation
1
1
Material Fragmentation
1
1
Stretched
1
1
Positioning Problem
1
1
Firing Problem
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Perforation of Esophagus
26
26
Perforation
16
16
No Clinical Signs, Symptoms or Conditions
14
14
Pleural Effusion
12
12
Insufficient Information
11
11
Laceration(s) of Esophagus
10
10
Abscess
9
9
No Known Impact Or Consequence To Patient
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Chest Pain
5
5
Dysphagia/ Odynophagia
5
5
Hemorrhage/Bleeding
5
5
Fever
4
4
No Code Available
4
4
Patient Problem/Medical Problem
3
3
Abdominal Pain
3
3
Pain
3
3
No Consequences Or Impact To Patient
2
2
Ischemia
2
2
Pneumothorax
2
2
Cyst(s)
2
2
Aspiration/Inhalation
2
2
Atrial Fibrillation
2
2
Failure of Implant
2
2
Foreign Body In Patient
2
2
Pericardial Effusion
2
2
Constipation
1
1
Syncope/Fainting
1
1
Device Embedded In Tissue or Plaque
1
1
Fungal Infection
1
1
Ambulation Difficulties
1
1
Weight Changes
1
1
Unspecified Infection
1
1
Low Blood Pressure/ Hypotension
1
1
Hematoma
1
1
Fatigue
1
1
Bacterial Infection
1
1
Cardiac Arrest
1
1
Abrasion
1
1
Pulmonary Edema
1
1
Respiratory Distress
1
1
Tissue Damage
1
1
Laceration(s)
1
1
Muscle Spasm(s)
1
1
Nausea
1
1
Excessive Tear Production
1
1
Hernia
1
1
Ulcer
1
1
Discomfort
1
1
Depression
1
1
Pneumonia
1
1
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