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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


Premarket Reviews
ManufacturerDecision
ENDOGASTRIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
G-SURG GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 18 18
2021 24 24
2022 16 16
2023 28 28
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 72 72
Insufficient Information 19 19
Detachment of Device or Device Component 8 8
Use of Device Problem 6 6
Loss of or Failure to Bond 6 6
Failure to Fire 5 5
Improper or Incorrect Procedure or Method 5 5
Therapeutic or Diagnostic Output Failure 4 4
Break 3 3
Mechanical Problem 3 3
Physical Resistance/Sticking 3 3
No Apparent Adverse Event 3 3
Difficult to Remove 2 2
Misfire 2 2
Material Deformation 2 2
Material Separation 2 2
Mechanical Jam 2 2
Entrapment of Device 1 1
Patient-Device Incompatibility 1 1
Device Fell 1 1
Positioning Problem 1 1
Material Fragmentation 1 1
Stretched 1 1
Obstruction of Flow 1 1
Material Twisted/Bent 1 1
Retraction Problem 1 1
Migration 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Difficult to Open or Close 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 32 32
Perforation of Esophagus 27 27
Pleural Effusion 16 16
No Clinical Signs, Symptoms or Conditions 16 16
Hemorrhage/Bleeding 15 15
Laceration(s) of Esophagus 12 12
Insufficient Information 11 11
Abscess 10 10
No Known Impact Or Consequence To Patient 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Bacterial Infection 8 8
Dysphagia/ Odynophagia 6 6
Chest Pain 5 5
Pleural Empyema 5 5
Fever 4 4
No Code Available 4 4
Pain 3 3
Hematoma 3 3
Ischemia 3 3
Abdominal Pain 3 3
Patient Problem/Medical Problem 3 3
Cyst(s) 2 2
Aspiration/Inhalation 2 2
Fungal Infection 2 2
Atrial Fibrillation 2 2
Failure of Implant 2 2
Pericardial Effusion 2 2
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 2 2
Pneumothorax 2 2
Low Blood Pressure/ Hypotension 1 1
Respiratory Failure 1 1
Ambulation Difficulties 1 1
Constipation 1 1
Excessive Tear Production 1 1
Ulcer 1 1
Tissue Damage 1 1
Pulmonary Edema 1 1
Device Embedded In Tissue or Plaque 1 1
Pulmonary Embolism 1 1
Pneumonia 1 1
Fistula 1 1
Laceration(s) 1 1
Hernia 1 1
Depression 1 1
Discomfort 1 1
Muscle Spasm(s) 1 1
Peritonitis 1 1
Cardiac Arrest 1 1
Obstruction/Occlusion 1 1

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