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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
2018 11 11
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 56 56
Insufficient Information 15 15
Detachment of Device or Device Component 7 7
Use of Device Problem 7 7
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
Device Operates Differently Than Expected 1 1
Physical Resistance 1 1
Device Inoperable 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
Device Issue 1 1
Detachment Of Device Component 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 27 27
Perforation 17 17
Pleural Effusion 14 14
No Clinical Signs, Symptoms or Conditions 14 14
Laceration(s) of Esophagus 12 12
Insufficient Information 11 11
No Known Impact Or Consequence To Patient 10 10
Abscess 9 9
Chest Pain 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Patient Problem/Medical Problem 7 7
Dysphagia/ Odynophagia 5 5
Hemorrhage/Bleeding 5 5
Fever 4 4
No Code Available 4 4
Abdominal Pain 3 3
Pain 3 3
Ischemia 2 2
Pneumothorax 2 2
No Consequences Or Impact To Patient 2 2
Cyst(s) 2 2
Aspiration/Inhalation 2 2
Atrial Fibrillation 2 2
Failure of Implant 2 2
Pericardial Effusion 2 2
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 1 1
Fungal Infection 1 1
Ambulation Difficulties 1 1
Weight Changes 1 1
Constipation 1 1
Syncope/Fainting 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
Excessive Tear Production 1 1
Hernia 1 1
Ulcer 1 1
Discomfort 1 1
Depression 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
Failure to Anastomose 1 1
Pneumonia 1 1

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