TPLC - Total Product Life Cycle

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Device	holder, needle, gastroenterologic
Product Code	FHQ
Regulation Number	876.4730
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	164	164
Retraction Problem	110	110
Use of Device Problem	58	58
Misfire	31	31
Break	26	26
Mechanical Problem	22	22
Adverse Event Without Identified Device or Use Problem	18	18
Device-Device Incompatibility	16	16
Difficult to Open or Close	9	9
Failure to Align	4	4
Material Twisted/Bent	4	4
Therapeutic or Diagnostic Output Failure	3	3
Contamination	3	3
Fracture	2	2
Material Separation	2	2
Defective Device	2	2
Defective Component	1	1
Tear, Rip or Hole in Device Packaging	1	1
Failure of Device to Self-Test	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Unsealed Device Packaging	1	1
Difficult to Remove	1	1
Material Fragmentation	1	1
Material Frayed	1	1
Entrapment of Device	1	1
Appropriate Term/Code Not Available	1	1
Activation Failure	1	1
Device Fell	1	1
Difficult to Advance	1	1
Packaging Problem	1	1
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	167	167
No Consequences Or Impact To Patient	62	62
Device Embedded In Tissue or Plaque	38	38
Foreign Body In Patient	37	37
No Known Impact Or Consequence To Patient	31	31
Insufficient Information	11	11
Hemorrhage/Bleeding	4	4
Pain	4	4
No Code Available	3	3
Hematoma	2	2
Constipation	1	1
Dyspareunia	1	1
No Information	1	1
Abscess	1	1
Erosion	1	1
Discomfort	1	1
No Patient Involvement	1	1