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	80	80
Insufficient Information	18	18
Mechanical Problem	14	14
No Apparent Adverse Event	7	7
Loss of or Failure to Bond	6	6
Device Dislodged or Dislocated	6	6
Use of Device Problem	6	6
Material Separation	6	6
Break	5	5
Difficult to Remove	5	5
Failure to Fire	5	5
Fluid/Blood Leak	4	4
Physical Resistance/Sticking	4	4
Difficult to Advance	4	4
Improper or Incorrect Procedure or Method	4	4
Difficult to Open or Close	4	4
Patient Device Interaction Problem	4	4
Difficult to Insert	4	4
Detachment of Device or Device Component	4	4
Entrapment of Device	3	3
Separation Failure	3	3
Mechanical Jam	3	3
Obstruction of Flow	3	3
Retraction Problem	3	3
Fracture	2	2
Material Deformation	2	2
Material Fragmentation	2	2
Positioning Problem	2	2
Defective Device	2	2
Difficult or Delayed Separation	1	1
Material Twisted/Bent	1	1
Misfire	1	1
Stretched	1	1
Material Protrusion/Extrusion	1	1
Activation Failure	1	1
Ejection Problem	1	1
Failure to Advance	1	1
Failure to Deliver	1	1
Contamination	1	1
Optical Obstruction	1	1
Deformation Due to Compressive Stress	1	1
Malposition of Device	1	1
Failure to Discharge	1	1
Separation Problem	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation of Esophagus	34	34
Perforation	32	32
No Clinical Signs, Symptoms or Conditions	31	31
Hemorrhage/Bleeding	17	17
Pleural Effusion	15	15
Laceration(s) of Esophagus	15	15
Abscess	13	13
Insufficient Information	11	11
Bacterial Infection	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Pain	8	8
Chest Pain	7	7
Dysphagia/ Odynophagia	7	7
Pleural Empyema	6	6
Fever	5	5
Abdominal Pain	5	5
Foreign Body In Patient	4	4
Unspecified Tissue Injury	3	3
Hematoma	3	3
Ischemia	3	3
Inflammation	2	2
Internal Organ Perforation	2	2
Pneumothorax	2	2
Rupture	2	2
Hernia	2	2
Abrasion	2	2
Aspiration/Inhalation	2	2
Atrial Fibrillation	2	2
Cyst(s)	2	2
Pericardial Effusion	2	2
Discomfort	2	2
Fluid Discharge	2	2
Fungal Infection	2	2
Obstruction/Occlusion	1	1
Respiratory Failure	1	1
Weight Changes	1	1
Tissue Breakdown	1	1
Syncope/Fainting	1	1
Device Embedded In Tissue or Plaque	1	1
Gastrointestinal Hemorrhage	1	1
Stenosis of the esophagus	1	1
Unspecified Gastrointestinal Problem	1	1
Hyponatremia	1	1
Swelling/ Edema	1	1
Dehydration	1	1
Cardiac Arrest	1	1
Fistula	1	1
Dyspnea	1	1
High Blood Pressure/ Hypertension	1	1
Low Blood Pressure/ Hypotension	1	1

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