TPLC - Total Product Life Cycle

show TPLC since

Device	snare, non-electrical
Regulation Description	Manual gastroenterology-urology surgical instrument and accessories.
Product Code	FGX
Regulation Number	876.4730
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Cut	99	99
Break	44	44
Detachment of Device or Device Component	38	38
Difficult to Open or Close	27	27
Retraction Problem	23	23
Mechanical Problem	17	17
Adverse Event Without Identified Device or Use Problem	15	15
Material Twisted/Bent	14	14
Fluid/Blood Leak	7	7
Entrapment of Device	6	6
Insufficient Information	6	6
Material Deformation	4	4
Device Contamination with Chemical or Other Material	4	4
Failure to Deliver Energy	3	3
Activation Problem	3	3
Device Contaminated During Manufacture or Shipping	2	2
Activation Failure	2	2
Activation, Positioning or Separation Problem	1	1
Separation Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Unintended Movement	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Difficult to Remove	1	1
Use of Device Problem	1	1
Mechanics Altered	1	1
Device Handling Problem	1	1
Material Protrusion/Extrusion	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	178	178
No Consequences Or Impact To Patient	23	23
Insufficient Information	15	15
Hemorrhage/Bleeding	14	14
No Known Impact Or Consequence To Patient	13	13
Hematoma	3	3
Foreign Body In Patient	3	3
Exposure to Body Fluids	3	3
Unspecified Tissue Injury	3	3
Perforation	2	2
Discomfort	1	1
Laceration(s)	1	1
Anxiety	1	1
Tissue Damage	1	1
Bacterial Infection	1	1
Device Embedded In Tissue or Plaque	1	1