TPLC - Total Product Life Cycle

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Device	resectoscope, working element
Regulation Description	Endoscope and accessories.
Product Code	FDC
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	9	9
Material Fragmentation	5	5
Arcing	5	5
Sparking	5	5
Unintended Electrical Shock	5	5
Excessive Heating	4	4
Overheating of Device	4	4
Material Separation	3	3
Smoking	3	3
Insufficient Information	3	3
Device Handling Problem	2	2
Material Twisted/Bent	2	2
Misconnection	2	2
Detachment of Device or Device Component	2	2
Fire	2	2
Loss of or Failure to Bond	1	1
Thermal Decomposition of Device	1	1
Difficult to Insert	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Device Dislodged or Dislocated	1	1
Electrical Shorting	1	1
Flare or Flash	1	1
Use of Device Problem	1	1
Arcing of Electrodes	1	1
Intermittent Energy Output	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Optical Obstruction	1	1
Power Problem	1	1
Temperature Problem	1	1
Explosion	1	1
Ambient Noise Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36	36
Insufficient Information	7	7
Burn(s)	6	6
Foreign Body In Patient	4	4
Electric Shock	3	3
Hemorrhage/Bleeding	3	3
Needle Stick/Puncture	2	2
Unspecified Tissue Injury	2	2
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hyperplasia	1	1
Perforation	1	1
Laceration(s)	1	1
Full thickness (Third Degree) Burn	1	1