TPLC - Total Product Life Cycle

• Device: light, catheter, fiberoptic, glass, ureteral
• Product Code: FCS
• Regulation Number: 876.4020
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	4	4
2020	8	8
2021	6	6
2022	19	19
2023	4	4
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Packaging Problem	10	10
Adverse Event Without Identified Device or Use Problem	8	8
Device Contamination with Chemical or Other Material	6	6
Output Problem	6	6
Contamination /Decontamination Problem	5	5
Device Unsafe to Use in Environment	4	4
Contamination	4	4
Use of Device Problem	3	3
Patient-Device Incompatibility	3	3
Insufficient Information	3	3
Therapeutic or Diagnostic Output Failure	2	2
Break	2	2
Structural Problem	2	2
Expiration Date Error	2	2
Fracture	2	2
Nonstandard Device	1	1
Delivered as Unsterile Product	1	1
No Device Output	1	1
Device Contamination with Body Fluid	1	1
Electrical /Electronic Property Problem	1	1
Defective Device	1	1
Difficult to Advance	1	1
Contamination of Device Ingredient or Reagent	1	1
Device Markings/Labelling Problem	1	1
Optical Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Activation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	29	29
Insufficient Information	22	22
No Known Impact Or Consequence To Patient	7	7
Renal Failure	3	3
Hemorrhage/Bleeding	2	2
Genital Bleeding	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Perforation	1	1
Uterine Perforation	1	1
Blood Loss	1	1
Burn(s)	1	1