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 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	69	69
Insufficient Information	19	19
Break	8	8
Use of Device Problem	8	8
Detachment of Device or Device Component	7	7
Device Operates Differently Than Expected	6	6
Failure to Fire	6	6
Improper or Incorrect Procedure or Method	5	5
Mechanical Problem	4	4
Loss of or Failure to Bond	4	4
Therapeutic or Diagnostic Output Failure	4	4
Physical Resistance	3	3
Difficult to Remove	3	3
Physical Resistance/Sticking	3	3
Retraction Problem	2	2
Leak/Splash	2	2
Loose or Intermittent Connection	2	2
Misfire	2	2
Difficult to Open or Close	2	2
Mechanical Jam	2	2
No Apparent Adverse Event	2	2
Material Deformation	2	2
Material Protrusion/Extrusion	2	2
Material Twisted/Bent	1	1
Positioning Problem	1	1
Torn Material	1	1
Device Dislodged or Dislocated	1	1
Malposition of Device	1	1
Patient-Device Incompatibility	1	1
Bent	1	1
Detachment Of Device Component	1	1
Entrapment of Device	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Material Separation	1	1
Sticking	1	1
Stretched	1	1
Device Inoperable	1	1
Device Issue	1	1
Obstruction of Flow	1	1
Device Fell	1	1
Appropriate Term/Code Not Available	1	1
Migration	1	1
Firing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation of Esophagus	30	30
Perforation	19	19
Pleural Effusion	17	17
Laceration(s) of Esophagus	16	16
No Known Impact Or Consequence To Patient	16	16
No Clinical Signs, Symptoms or Conditions	14	14
Insufficient Information	11	11
Abscess	11	11
Chest Pain	11	11
Fever	8	8
No Consequences Or Impact To Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Patient Problem/Medical Problem	7	7
Hemorrhage/Bleeding	6	6
Dysphagia/ Odynophagia	5	5
No Code Available	5	5
Pain	4	4
Tissue Damage	3	3
Abdominal Pain	3	3
Internal Organ Perforation	3	3
Failure to Anastomose	2	2
Failure of Implant	2	2
Unspecified Infection	2	2
Ischemia	2	2
Laceration(s)	2	2
Pneumothorax	2	2
Aspiration/Inhalation	2	2
Atrial Fibrillation	2	2
Cyst(s)	2	2
Hematoma	2	2
Foreign Body In Patient	2	2
Pericardial Effusion	2	2
Constipation	1	1
Syncope/Fainting	1	1
Test Result	1	1
Device Embedded In Tissue or Plaque	1	1
Fungal Infection	1	1
Ambulation Difficulties	1	1
Weight Changes	1	1
Difficulty Chewing	1	1
Low Blood Pressure/ Hypotension	1	1
Extravasation	1	1
Fatigue	1	1
Bacterial Infection	1	1
Cardiac Arrest	1	1
Abrasion	1	1
Anemia	1	1
Pulmonary Edema	1	1
Respiratory Distress	1	1
Pneumonia	1	1
Excessive Tear Production	1	1
Hernia	1	1
Ulcer	1	1
Discomfort	1	1
Injury	1	1
Depression	1	1
Muscle Spasm(s)	1	1
Nausea	1	1
Inflammation	1	1