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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)
Regulation Description Endoscope and accessories.
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
2020 18 18
2021 24 24
2022 16 16
2023 28 28
2024 41 41
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 75 75
Insufficient Information 19 19
Use of Device Problem 9 9
Mechanical Problem 9 9
Detachment of Device or Device Component 7 7
Loss of or Failure to Bond 6 6
Improper or Incorrect Procedure or Method 5 5
Device Dislodged or Dislocated 5 5
Failure to Fire 4 4
Fluid/Blood Leak 4 4
No Apparent Adverse Event 4 4
Material Separation 3 3
Therapeutic or Diagnostic Output Failure 3 3
Physical Resistance/Sticking 3 3
Break 3 3
Patient Device Interaction Problem 3 3
Positioning Problem 2 2
Difficult to Remove 2 2
Retraction Problem 2 2
Difficult to Advance 2 2
Material Deformation 1 1
Failure to Deliver 1 1
Material Fragmentation 1 1
Activation Failure 1 1
Contamination 1 1
Difficult to Open or Close 1 1
Material Protrusion/Extrusion 1 1
Entrapment of Device 1 1
Mechanical Jam 1 1
Separation Problem 1 1
Fracture 1 1
Difficult to Insert 1 1
Material Twisted/Bent 1 1
Obstruction of Flow 1 1
Misfire 1 1
Stretched 1 1
Biocompatibility 1 1
Malposition of Device 1 1
Optical Obstruction 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation 32 32
Perforation of Esophagus 30 30
No Clinical Signs, Symptoms or Conditions 17 17
Pleural Effusion 17 17
Hemorrhage/Bleeding 16 16
Abscess 12 12
Laceration(s) of Esophagus 12 12
Insufficient Information 11 11
Bacterial Infection 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Dysphagia/ Odynophagia 8 8
No Known Impact Or Consequence To Patient 7 7
Pain 7 7
Chest Pain 6 6
Pleural Empyema 6 6
Fever 5 5
Abdominal Pain 4 4
Hematoma 3 3
Patient Problem/Medical Problem 3 3
Ischemia 3 3
Aspiration/Inhalation 2 2
Atrial Fibrillation 2 2
Cyst(s) 2 2
Failure of Implant 2 2
Pneumothorax 2 2
Fluid Discharge 2 2
No Code Available 2 2
Pericardial Effusion 2 2
Fungal Infection 2 2
Discomfort 2 2
Swelling/ Edema 1 1
Rupture 1 1
Vomiting 1 1
Sepsis 1 1
Pulmonary Edema 1 1
Pneumonia 1 1
Nausea 1 1
Laceration(s) 1 1
Respiratory Failure 1 1
Obstruction/Occlusion 1 1
Ulcer 1 1
Peritonitis 1 1
Hernia 1 1
Excessive Tear Production 1 1
Hyponatremia 1 1
Stenosis of the esophagus 1 1
Syncope/Fainting 1 1
Device Embedded In Tissue or Plaque 1 1
Foreign Body In Patient 1 1
Weight Changes 1 1

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