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 Code	ODE
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	91	91
Insufficient Device Problem Information	18	18
Mechanical Problem	10	10
No Apparent Adverse Event	7	7
Loss of or Failure to Bond	6	6
Use of Device Problem	6	6
Material Separation	6	6
Physical Resistance/Sticking	5	5
Device Dislodged or Dislocated	5	5
Fluid/Blood Leak	4	4
Difficult to Advance	4	4
Difficult to Remove	4	4
Patient Device Interaction Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Difficult to Insert	4	4
Difficult to Open or Close	4	4
Failure to Fire	4	4
Detachment of Device or Device Component	4	4
Separation Failure	3	3
Mechanical Jam	3	3
Retraction Problem	3	3
Obstruction of Flow	2	2
Material Deformation	2	2
Fracture	2	2
Biocompatibility	1	1
Failure to Discharge	1	1
Deformation Due to Compressive Stress	1	1
Optical Obstruction	1	1
Activation Failure	1	1
Material Protrusion/Extrusion	1	1
Difficult or Delayed Separation	1	1
Material Twisted/Bent	1	1
Stretched	1	1
Material Fragmentation	1	1
Ejection Problem	1	1
Failure to Deliver	1	1
Contamination	1	1
Positioning Problem	1	1
Malposition of Device	1	1
Entrapment of Device	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation of Esophagus	36	36
No Clinical Signs, Symptoms or Conditions	33	33
Perforation	33	33
Hemorrhage/Blood Loss/Bleeding	17	17
Laceration(s) of Esophagus	17	17
Pleural Effusion	15	15
Abscess	13	13
Insufficient Information	12	12
Bacterial Infection	10	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Pain	8	8
Dysphagia/ Odynophagia	7	7
Chest Pain	7	7
Abdominal Pain	6	6
Pleural Empyema	6	6
Fever	5	5
Internal Organ Perforation	4	4
Unspecified Tissue Injury	4	4
Foreign Body In Patient	4	4
Hernia	3	3
Hematoma	3	3
Inflammation	3	3
Ischemia	3	3
Pulmonary Edema	2	2
Fluid Discharge	2	2
Pneumonia	2	2
Discomfort	2	2
Pericardial Effusion	2	2
Rupture	2	2
Atrial Fibrillation	2	2
Abrasion	2	2
Cyst(s)	2	2
Aspiration/Inhalation	2	2
Unspecified Gastrointestinal Problem	2	2
Fungal Infection	2	2
Pneumothorax	2	2
Obstruction/Occlusion	1	1
Cardiac Arrest	1	1
Peritonitis	1	1
Chills	1	1
Stenosis of the esophagus	1	1
Vomiting	1	1
Vascular Dissection	1	1
Dehydration	1	1
Dyspnea	1	1
Gastrointestinal Hemorrhage	1	1
Laceration(s)	1	1
Sepsis	1	1
Nausea	1	1
Hyponatremia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Merit Medical Systems, Inc.	II	Apr-21-2025