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
2017	19	19
2018	19	19
2019	17	17
2020	56	56
2021	57	57
2022	8	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	57	57
Failure to Power Up	52	52
Protective Measures Problem	16	16
Unexpected Shutdown	13	13
Power Problem	9	9
Insufficient Information	8	8
Loss of Power	6	6
Noise, Audible	4	4
Device Displays Incorrect Message	4	4
Electrical Shorting	3	3
Thermal Decomposition of Device	3	3
No Display/Image	2	2
Melted	2	2
Device Emits Odor	2	2
Defective Component	2	2
Inadequate Lighting	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Device Operates Differently Than Expected	2	2
No Apparent Adverse Event	2	2
Break	2	2
Scratched Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Electrical Power Problem	1	1
Sparking	1	1
Optical Obstruction	1	1
Device Issue	1	1
Smoking	1	1
Device Inoperable	1	1
Use of Device Problem	1	1
No Device Output	1	1
Poor Quality Image	1	1
Electrical /Electronic Property Problem	1	1
Fire	1	1
Image Display Error/Artifact	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	81
No Known Impact Or Consequence To Patient	46	46
No Patient Involvement	33	33
No Information	8	8
No Consequences Or Impact To Patient	5	5
Full thickness (Third Degree) Burn	3	3
Blurred Vision	1	1
No Code Available	1	1

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