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	89	89
Insufficient Information	24	24
Break	8	8
Use of Device Problem	8	8
Detachment of Device or Device Component	8	8
Loss of or Failure to Bond	6	6
Failure to Fire	6	6
Device Operates Differently Than Expected	6	6
Improper or Incorrect Procedure or Method	5	5
Mechanical Problem	4	4
Therapeutic or Diagnostic Output Failure	4	4
Physical Resistance/Sticking	3	3
Difficult to Remove	3	3
Physical Resistance	3	3
No Apparent Adverse Event	3	3
Difficult to Open or Close	3	3
Misfire	2	2
Mechanical Jam	2	2
Loose or Intermittent Connection	2	2
Material Deformation	2	2
Retraction Problem	2	2
Material Separation	2	2
Material Protrusion/Extrusion	2	2
Device Dislodged or Dislocated	2	2
Leak/Splash	2	2
Detachment Of Device Component	1	1
Device Issue	1	1
Positioning Problem	1	1
Device Fell	1	1
Patient-Device Incompatibility	1	1
Torn Material	1	1
Device Inoperable	1	1
Firing Problem	1	1
Appropriate Term/Code Not Available	1	1
Migration	1	1
Sticking	1	1
Bent	1	1
Obstruction of Flow	1	1
Material Twisted/Bent	1	1
Stretched	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Entrapment of Device	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation	35	35
Perforation of Esophagus	31	31
Pleural Effusion	21	21
Laceration(s) of Esophagus	18	18
No Known Impact Or Consequence To Patient	16	16
Hemorrhage/Bleeding	16	16
No Clinical Signs, Symptoms or Conditions	16	16
Abscess	12	12
Insufficient Information	11	11
Chest Pain	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Fever	8	8
Bacterial Infection	8	8
Patient Problem/Medical Problem	7	7
No Consequences Or Impact To Patient	7	7
Dysphagia/ Odynophagia	6	6
Pleural Empyema	5	5
No Code Available	5	5
Hematoma	4	4
Pain	4	4
Internal Organ Perforation	3	3
Ischemia	3	3
Tissue Damage	3	3
Abdominal Pain	3	3
Aspiration/Inhalation	2	2
Cyst(s)	2	2
Atrial Fibrillation	2	2
Fungal Infection	2	2
Pericardial Effusion	2	2
Failure of Implant	2	2
Foreign Body In Patient	2	2
Pneumothorax	2	2
Unspecified Infection	2	2
Laceration(s)	2	2
Failure to Anastomose	2	2
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Constipation	1	1
Difficulty Chewing	1	1
Pulmonary Embolism	1	1
Fistula	1	1
Excessive Tear Production	1	1
Ulcer	1	1
Ambulation Difficulties	1	1
Pulmonary Edema	1	1
Extravasation	1	1
Device Embedded In Tissue or Plaque	1	1
Pneumonia	1	1
Depression	1	1
Discomfort	1	1