TPLC - Total Product Life Cycle

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Device	microscope, operating & accessories, ac-powered, ophthalmic
Regulation Description	Surgical microscope and accessories.
Product Code	HRM
Regulation Number	878.4700
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Loose or Intermittent Connection	60	60
Unintended Movement	45	45
Break	7	7
Optical Problem	7	7
Appropriate Term/Code Not Available	7	7
Detachment of Device or Device Component	6	6
Unstable	4	4
Misfocusing	4	4
Device Fell	3	3
Defective Component	3	3
Failure to Align	2	2
Device Dislodged or Dislocated	2	2
Optical Obstruction	2	2
Device Slipped	1	1
Fitting Problem	1	1
No Display/Image	1	1
Image Display Error/Artifact	1	1
Poor Quality Image	1	1
Defective Device	1	1
Key or Button Unresponsive/not Working	1	1
Material Too Rigid or Stiff	1	1
Component Missing	1	1
Material Twisted/Bent	1	1
Particulates	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Handling Problem	1	1
Computer Software Problem	1	1
Unintended System Motion	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	81
Insufficient Information	40	40
Capsular Bag Tear	11	11
No Known Impact Or Consequence To Patient	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Consequences Or Impact To Patient	3	3
Intraocular Pressure Increased	2	2
Inflammation	2	2
Rupture	2	2
Laceration(s)	2	2
Visual Impairment	2	2
Eye Injury	2	2
Bruise/Contusion	2	2
Phototoxicity	1	1
Vitreous Detachment	1	1
Abrasion	1	1
Retinal Injury	1	1
No Patient Involvement	1	1
Unspecified Eye / Vision Problem	1	1
Discomfort	1	1
Prolapse	1	1
Swelling/ Edema	1	1
Hemorrhage/Bleeding	1	1