TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Fire	2278	2278
Premature Activation	555	555
Break	349	349
Use of Device Problem	333	333
Material Integrity Problem	167	167
Detachment of Device or Device Component	144	144
Difficult or Delayed Positioning	97	97
Human-Device Interface Problem	94	94
Device Dislodged or Dislocated	83	83
Positioning Failure	70	70
Defective Device	63	63
Difficult to Remove	62	62
Material Separation	62	62
Device Difficult to Setup or Prepare	61	61
Adverse Event Without Identified Device or Use Problem	58	58
Detachment Of Device Component	57	57
Migration or Expulsion of Device	57	57
Activation, Positioning or Separation Problem	52	52
Material Too Soft/Flexible	42	42
Misfire	40	40
Premature Separation	39	39
Material Deformation	32	32
Improper or Incorrect Procedure or Method	32	32
Entrapment of Device	31	31
Device Operates Differently Than Expected	26	26
Device-Device Incompatibility	22	22
Fracture	21	21
Separation Failure	20	20
Unintended Movement	19	19
Difficult or Delayed Separation	16	16
Misassembly by Users	16	16
Compatibility Problem	15	15
Suction Problem	11	11
Device Handling Problem	10	10
Mechanical Problem	8	8
Off-Label Use	8	8
Degraded	8	8
Device Misassembled During Manufacturing /Shipping	7	7
Material Twisted/Bent	7	7
Difficult To Position	6	6
Mechanical Jam	6	6
Shelf Life Exceeded	6	6
Component Missing	5	5
Accessory Incompatible	5	5
Physical Resistance/Sticking	5	5
Migration	4	4
Appropriate Term/Code Not Available	4	4
Inability to Irrigate	4	4
Insufficient Information	4	4
Activation Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2637	2637
No Consequences Or Impact To Patient	869	869
Foreign Body In Patient	184	184
Hemorrhage/Bleeding	128	128
No Known Impact Or Consequence To Patient	127	127
No Patient Involvement	83	83
Insufficient Information	30	30
Gastrointestinal Hemorrhage	28	28
Hemostasis	17	17
Death	16	16
Blood Loss	9	9
Perforation	8	8
No Code Available	7	7
Tissue Damage	6	6
No Information	6	6
Peritonitis	6	6
Laceration(s) of Esophagus	5	5
Obstruction/Occlusion	4	4
Abdominal Pain	4	4
Asthma	3	3
Fever	3	3
Abdominal Distention	3	3
Laceration(s)	3	3
Pain	3	3
Reaction	3	3
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
Low Blood Pressure/ Hypotension	3	3
Low Oxygen Saturation	3	3
Device Embedded In Tissue or Plaque	3	3
Bradycardia	2	2
Dysphagia/ Odynophagia	2	2
Respiratory Distress	2	2
Malaise	1	1
Foreign Body Reaction	1	1
Inflammation	1	1
Injury	1	1
Stenosis of the esophagus	1	1
Aspiration/Inhalation	1	1
Chest Pain	1	1
Vomiting	1	1
Bowel Perforation	1	1
Cardiopulmonary Arrest	1	1
Pneumonia	1	1
Hypoxia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Airway Obstruction	1	1
Ischemia Stroke	1	1
Hypovolemia	1	1
Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Endoscopy	II	Jun-28-2011
2	Cook Endoscopy	II	Oct-19-2010
3	Micro-Tech Usa	II	Nov-18-2020
4	Olympus Corporation of the Americas	II	Apr-20-2023