TPLC - Total Product Life Cycle

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Device	photocoagulator and accessories
Regulation Description	Ophthalmic photocoagulator.
Product Code	HQB
Regulation Number	886.4690
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2	2
Fitting Problem	2	2
Use of Device Problem	2	2
Mechanical Problem	2	2
Ejection Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Environmental Particulates	1	1
Smoking	1	1
Unintended Ejection	1	1
Firing Problem	1	1
Lack of Effect	1	1
Accessory Incompatible	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	10	10
Eye Injury	3	3
Retinal Injury	2	2
Eye Burn	2	2
Intraocular Infection	1	1
No Consequences Or Impact To Patient	1	1
Conjunctivitis	1	1
Unspecified Eye / Vision Problem	1	1
Visual Disturbances	1	1
Insufficient Information	1	1