TPLC - Total Product Life Cycle

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Device	microscope, surgical
Regulation Description	Surgical microscope and accessories.
Product Code	EPT
Regulation Number	878.4700
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Electrical /Electronic Property Problem	73	73
Material Split, Cut or Torn	14	14
Device Tipped Over	8	8
Detachment of Device or Device Component	8	8
Insufficient Device Problem Information	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Use of Device Problem	6	6
Device Dislodged or Dislocated	6	6
Device Fell	5	5
Unexpected Shutdown	4	4
Break	4	4
Optical Problem	3	3
Optical Obstruction	2	2
Display or Visual Feedback Problem	2	2
Mechanical Problem	1	1
Off-Label Use	1	1
Activation Problem	1	1
Defective Device	1	1
Failure to Clean Adequately	1	1
Fogging	1	1
Component Missing	1	1
Product Quality Problem	1	1
Material Separation	1	1
Environmental Particulates	1	1
Activation Failure	1	1
Explosion	1	1
Computer Software Problem	1	1
Fracture	1	1
Image Orientation Incorrect	1	1
Insufficient Cooling	1	1
Overheating of Device	1	1
Loose or Intermittent Connection	1	1
Mechanical Jam	1	1
Misfocusing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	136	136
Partial thickness (Second Degree) Burn	7	7
Burn(s)	5	5
Insufficient Information	2	2
Full thickness (Third Degree) Burn	2	2
Bruise/Contusion	2	2
Superficial (First Degree) Burn	1	1
Syncope/Fainting	1	1
Intraoperative Cardiac Valve Injury	1	1
Head Injury	1	1
Abrasion	1	1
Crushing Injury	1	1
Capsular Bag Tear	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Intraocular Pressure Decreased	1	1
No Consequences Or Impact To Patient	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Leica Microsystems, Inc.	II	Dec-09-2022