TPLC - Total Product Life Cycle

• Device: dislodger, stone, flexible
• Regulation Description: Ureteral stone dislodger.
• Product Code: FGO
• Regulation Number: 876.4680
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2020	19	19
2021	14	14
2022	18	18
2023	14	14
2024	19	19
2025	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	28	28
Peeled/Delaminated	26	26
Difficult to Open or Close	22	22
Break	14	14
Material Split, Cut or Torn	7	7
Adverse Event Without Identified Device or Use Problem	5	5
Unsealed Device Packaging	2	2
Material Twisted/Bent	2	2
Material Deformation	2	2
Packaging Problem	2	2
Difficult to Advance	1	1
Device Fell	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Difficult to Remove	1	1
Degraded	1	1
Shipping Damage or Problem	1	1
Use of Device Problem	1	1
Retraction Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Appropriate Term/Code Not Available	1	1
Loose or Intermittent Connection	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	64	64
No Consequences Or Impact To Patient	14	14
Insufficient Information	6	6
Foreign Body In Patient	4	4
No Known Impact Or Consequence To Patient	3	3
Sepsis	1	1
No Code Available	1	1
Hematuria	1	1
Hematoma	1	1
Inflammation	1	1
Perforation	1	1
Obstruction/Occlusion	1	1
Urethral Stenosis/Stricture	1	1
Injury	1	1
Pain	1	1
Unspecified Kidney or Urinary Problem	1	1
Myocardial Infarction	1	1
Urinary Tract Infection	1	1