TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Poor Quality Image	284	284
No Display/Image	91	91
Break	58	58
Communication or Transmission Problem	57	57
Display or Visual Feedback Problem	27	27
Scratched Material	24	24
Erratic or Intermittent Display	21	21
Dent in Material	16	16
Material Split, Cut or Torn	16	16
Optical Problem	14	14
Crack	13	13
Loose or Intermittent Connection	13	13
Material Discolored	12	12
Output Problem	11	11
Image Display Error/Artifact	11	11
Material Integrity Problem	11	11
Leak/Splash	10	10
Image Orientation Incorrect	9	9
Contamination	9	9
Fracture	7	7
Defective Component	6	6
Failure to Clean Adequately	5	5
Defective Device	4	4
Connection Problem	4	4
Mechanical Problem	4	4
Material Deformation	4	4
Electrical /Electronic Property Problem	3	3
Optical Discoloration	3	3
Material Opacification	3	3
Sharp Edges	3	3
Unintended Movement	2	2
Optical Distortion	2	2
Degraded	2	2
Gas/Air Leak	2	2
Detachment of Device or Device Component	2	2
Circuit Failure	2	2
Corroded	1	1
Optical Obstruction	1	1
Self-Activation or Keying	1	1
Mechanical Jam	1	1
Fluid/Blood Leak	1	1
Flushing Problem	1	1
Misfocusing	1	1
Device Contamination with Chemical or Other Material	1	1
Contamination of Device Ingredient or Reagent	1	1
Moisture or Humidity Problem	1	1
Material Fragmentation	1	1
Fogging	1	1
Key or Button Unresponsive/not Working	1	1
Contamination /Decontamination Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	625	625
Insufficient Information	4	4
No Known Impact Or Consequence To Patient	1	1
Foreign Body In Patient	1	1