TPLC - Total Product Life Cycle

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Device	camera, surgical and accessories
Regulation Description	Surgical camera and accessories.
Product Code	KQM
Regulation Number	878.4160
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Display or Visual Feedback Problem	39	39
No Display/Image	12	12
Insufficient Information	8	8
Detachment of Device or Device Component	8	8
Break	5	5
Fracture	4	4
Failure to Power Up	3	3
Electromagnetic Interference	3	3
Image Display Error/Artifact	2	2
Device Fell	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Erratic or Intermittent Display	2	2
Power Problem	2	2
Circuit Failure	1	1
Compatibility Problem	1	1
Unexpected Shutdown	1	1
Crack	1	1
Poor Quality Image	1	1
Smoking	1	1
Defective Device	1	1
Solder Joint Fracture	1	1
Device Handling Problem	1	1
Connection Problem	1	1
Self-Activation or Keying	1	1
Corroded	1	1
Loss of Power	1	1
Improper or Incorrect Procedure or Method	1	1
Intermittent Communication Failure	1	1
Loss of or Failure to Bond	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	92	92
Insufficient Information	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Superficial (First Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Barco N.V.	II	Feb-02-2024
2	Baxter Healthcare Corporation	II	Jul-05-2024
3	Steris Corporation	II	Feb-12-2026