TPLC - Total Product Life Cycle

• Device: image, illumination, fiberoptic, for endoscope
• Product Code: FFS
• Regulation Number: 876.1500
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2016	7	7
2017	19	19
2018	19	19
2019	17	17
2020	56	56
2021	57	57
2022	10	10
2023	6	6
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	61	61
Failure to Power Up	55	55
Protective Measures Problem	16	16
Unexpected Shutdown	15	15
Insufficient Information	10	10
Power Problem	9	9
Loss of Power	7	7
Noise, Audible	4	4
Device Displays Incorrect Message	4	4
Melted	3	3
Device Operates Differently Than Expected	3	3
Thermal Decomposition of Device	3	3
Electrical Shorting	3	3
Device Emits Odor	2	2
Break	2	2
Defective Component	2	2
Device Inoperable	2	2
Smoking	2	2
Inadequate Lighting	2	2
No Apparent Adverse Event	2	2
No Display/Image	2	2
Electrical /Electronic Property Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Electrical Power Problem	1	1
Optical Obstruction	1	1
Use of Device Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Sparking	1	1
Fire	1	1
No Device Output	1	1
Scratched Material	1	1
Device Issue	1	1
Image Display Error/Artifact	1	1
Poor Quality Image	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	88	88
No Known Impact Or Consequence To Patient	50	50
No Patient Involvement	33	33
No Information	8	8
No Consequences Or Impact To Patient	7	7
Full thickness (Third Degree) Burn	3	3
No Code Available	1	1
Insufficient Information	1	1
Burn, Thermal	1	1
Laceration(s)	1	1
Blurred Vision	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	Jun-05-2017