TPLC - Total Product Life Cycle

• Device: light, surgical, accessories
• Regulation Description: Surgical lamp.
• Product Code: FTA
• Regulation Number: 878.4580
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2021	20	20
2022	14	14
2023	105	105
2024	29	29
2025	19	19
2026	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	118	118
Crack	19	19
Display or Visual Feedback Problem	10	10
Unsealed Device Packaging	9	9
Device Fell	7	7
Contamination	7	7
Break	2	2
No Display/Image	2	2
Peeled/Delaminated	2	2
Material Puncture/Hole	2	2
Contamination /Decontamination Problem	2	2
Product Quality Problem	2	2
Device Contamination with Chemical or Other Material	2	2
No Apparent Adverse Event	2	2
Computer Software Problem	2	2
Flaked	2	2
Material Split, Cut or Torn	1	1
Separation Problem	1	1
Output Problem	1	1
Image Display Error/Artifact	1	1
Insufficient Information	1	1
Defective Component	1	1
Defective Device	1	1
Use of Device Problem	1	1
Component Missing	1	1
Structural Problem	1	1
Mechanics Altered	1	1
Delivered as Unsterile Product	1	1
Corroded	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Mechanical Jam	1	1
Intermittent Loss of Power	1	1
Device Contaminated at the User Facility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	172	172
Insufficient Information	17	17
Unspecified Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Steris Corporation	II	Apr-28-2023