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	13	13
No Display/Image	11	11
Insufficient Information	8	8
Poor Quality Image	7	7
Break	5	5
Detachment of Device or Device Component	5	5
Device Fell	4	4
Fracture	4	4
Failure to Power Up	3	3
Power Problem	3	3
Electromagnetic Interference	3	3
Unexpected Shutdown	2	2
Image Display Error/Artifact	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Corroded	2	2
Loss of Power	2	2
Circuit Failure	1	1
Compatibility Problem	1	1
Crack	1	1
Electrical Power Problem	1	1
Collapse	1	1
Smoking	1	1
Solder Joint Fracture	1	1
Device Handling Problem	1	1
Connection Problem	1	1
Self-Activation or Keying	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	55	55
No Consequences Or Impact To Patient	9	9
Insufficient Information	6	6
No Known Impact Or Consequence To Patient	2	2
Superficial (First Degree) Burn	1	1
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Not Applicable	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
No Patient Involvement	1	1

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