TPLC - Total Product Life Cycle

• Device: stylet, ureteral
• Product Code: EYA
• Regulation Number: 876.5130
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2017	7	7
2018	13	13
2019	11	11
2020	8	8
2021	33	33
2022	21	21
2023	26	26
2024	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Damaged by Another Device	40	40
Material Split, Cut or Torn	36	36
Break	15	15
Unraveled Material	14	14
Material Separation	8	8
Flaked	6	6
Material Fragmentation	6	6
Insufficient Information	5	5
Material Integrity Problem	4	4
Detachment of Device or Device Component	3	3
Fracture	3	3
Material Frayed	3	3
Peeled/Delaminated	3	3
Device Fell	3	3
Detachment Of Device Component	3	3
No Apparent Adverse Event	2	2
Entrapment of Device	2	2
Material Deformation	2	2
Material Protrusion/Extrusion	1	1
Device Dislodged or Dislocated	1	1
Mechanical Problem	1	1
Device Markings/Labelling Problem	1	1
Shipping Damage or Problem	1	1
Material Twisted/Bent	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Handling Problem	1	1
Contamination	1	1
Uncoiled	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	79	79
Foreign Body In Patient	18	18
No Consequences Or Impact To Patient	18	18
No Known Impact Or Consequence To Patient	9	9
Insufficient Information	5	5
Device Embedded In Tissue or Plaque	4	4
Injury	2	2
Uterine Perforation	1	1
No Code Available	1	1
Sepsis	1	1
Gastrointestinal Hemorrhage	1	1
No Information	1	1
Perforation	1	1
Anemia	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Abscess	1	1
Tissue Damage	1	1