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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 CodeODE
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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