• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 3

MDR Year MDR Reports MDR Events
2016 12 12
2017 12 12
2018 10 10
2019 10 10
2020 18 18
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 25 25
Device Operates Differently Than Expected 6 6
Break 5 5
Use of Device Problem 5 5
Detachment of Device or Device Component 4 4
Therapeutic or Diagnostic Output Failure 4 4
Physical Resistance 3 3
Mechanical Problem 3 3
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Failure to Fire 2 2
Material Protrusion/Extrusion 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 1 1
Migration 1 1
Firing Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Mechanical Jam 1 1
Difficult to Open or Close 1 1
Material Deformation 1 1
Torn Material 1 1
Patient-Device Incompatibility 1 1
Bent 1 1
Improper or Incorrect Procedure or Method 1 1
Device Issue 1 1
Misfire 1 1
Detachment Of Device Component 1 1
Difficult to Insert 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Sticking 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
Pleural Effusion 8 8
Patient Problem/Medical Problem 7 7
No Consequences Or Impact To Patient 7 7
Perforation of Esophagus 7 7
Chest Pain 6 6
No Code Available 5 5
Laceration(s) of Esophagus 5 5
Tissue Damage 3 3
Fever 3 3
Perforation 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Failure of Implant 2 2
Failure to Anastomose 2 2
Cyst(s) 2 2
Pain 2 2
Cardiac Arrest 1 1
Pneumothorax 1 1
Respiratory Distress 1 1
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Nausea 1 1
Discomfort 1 1
Depression 1 1
Constipation 1 1
Weight Changes 1 1
Difficulty Chewing 1 1
Foreign Body In Patient 1 1
Dysphagia/ Odynophagia 1 1
Extravasation 1 1
Fatigue 1 1
Abrasion 1 1
Abscess 1 1
Anemia 1 1
Muscle Spasm(s) 1 1
Hematoma 1 1
Ambulation Difficulties 1 1
Excessive Tear Production 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

-
-