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
2014	5	5
2015	4	4
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	63	63
Failure to Power Up	56	56
Protective Measures Problem	16	16
Unexpected Shutdown	15	15
Insufficient Information	10	10
Power Problem	9	9
Loss of Power	7	7
Smoking	6	6
Device Displays Incorrect Message	5	5
Noise, Audible	4	4
Thermal Decomposition of Device	3	3
Inadequate Lighting	3	3
Device Operates Differently Than Expected	3	3
Melted	3	3
Device Inoperable	3	3
Device Emits Odor	3	3
Electrical Shorting	3	3
No Display/Image	2	2
Break	2	2
Fire	2	2
Defective Component	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Electrical /Electronic Property Problem	2	2
No Apparent Adverse Event	2	2
Sparking	1	1
Electrical Power Problem	1	1
Poor Quality Image	1	1
Image Display Error/Artifact	1	1
Therapeutic or Diagnostic Output Failure	1	1
Scratched Material	1	1
Use of Device Problem	1	1
Optical Obstruction	1	1
Loose or Intermittent Connection	1	1
Device Issue	1	1
No Device Output	1	1
Hole In Material	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	56	56
No Patient Involvement	33	33
No Information	9	9
No Consequences Or Impact To Patient	9	9
Full thickness (Third Degree) Burn	3	3
No Code Available	1	1
Burn, Thermal	1	1
Insufficient Information	1	1
Laceration(s)	1	1
Blurred Vision	1	1
Partial thickness (Second Degree) Burn	1	1

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