TPLC - Total Product Life Cycle

show TPLC since

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	165	165
Retraction Problem	111	111
Use of Device Problem	64	64
Misfire	36	36
Break	26	26
Mechanical Problem	23	23
Adverse Event Without Identified Device or Use Problem	19	19
Device-Device Incompatibility	16	16
Difficult to Open or Close	9	9
Failure to Align	5	5
Material Twisted/Bent	4	4
Contamination	3	3
Therapeutic or Diagnostic Output Failure	3	3
Fracture	2	2
Defective Device	2	2
Material Separation	2	2
Material Fragmentation	1	1
Unsealed Device Packaging	1	1
Failure of Device to Self-Test	1	1
Material Deformation	1	1
Packaging Problem	1	1
Positioning Problem	1	1
Difficult to Advance	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Entrapment of Device	1	1
Difficult to Remove	1	1
Device Fell	1	1
Defective Component	1	1
Tear, Rip or Hole in Device Packaging	1	1
Suction Problem	1	1
Appropriate Term/Code Not Available	1	1
Material Frayed	1	1
Activation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	179	179
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
No Information	1	1
Constipation	1	1
Dyspareunia	1	1
Unspecified Tissue Injury	1	1
Abscess	1	1
Erosion	1	1
Discomfort	1	1
No Patient Involvement	1	1