TPLC - Total Product Life Cycle

• Device: resectoscope, working element
• Product Code: FDC
• Regulation Number: 876.1500
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2016	1	1
2017	9	9
2018	4	4
2019	14	14
2020	10	10
2021	5	5
2022	5	5
2023	10	10
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	24	24
Temperature Problem	5	5
Adverse Event Without Identified Device or Use Problem	3	3
Unintended Electrical Shock	3	3
Unintended Power Up	3	3
Material Fragmentation	3	3
Grounding Malfunction	3	3
Mechanical Problem	3	3
Overheating of Device	3	3
Material Separation	3	3
Thermal Decomposition of Device	2	2
Fire	2	2
Fracture	2	2
Bent	2	2
Arcing of Electrodes	2	2
Sparking	2	2
Detachment of Device or Device Component	2	2
Electrical Shorting	1	1
Flare or Flash	1	1
Material Integrity Problem	1	1
Ambient Noise Problem	1	1
Connection Problem	1	1
Defective Device	1	1
Excessive Heating	1	1
Power Problem	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Detachment Of Device Component	1	1
Material Discolored	1	1
Electrical /Electronic Property Problem	1	1
Entrapment of Device	1	1
Smoking	1	1
Difficult to Insert	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15	15
No Consequences Or Impact To Patient	14	14
Foreign Body In Patient	6	6
Insufficient Information	6	6
No Known Impact Or Consequence To Patient	3	3
Full thickness (Third Degree) Burn	3	3
Lead(s), Burn(s) From	3	3
Shock	2	2
Burn, Thermal	2	2
Electric Shock	2	2
Burn(s)	2	2
Hemorrhage/Bleeding	2	2
No Patient Involvement	2	2
Laceration(s)	1	1
Perforation	1	1
Death	1	1
Electrocution	1	1
Blood Loss	1	1
Tissue Damage	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Device Embedded In Tissue or Plaque	1	1
Unspecified Tissue Injury	1	1