TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
1. K203226 TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Poor Quality Image	266	266
No Display/Image	86	86
Communication or Transmission Problem	53	53
Break	48	48
Display or Visual Feedback Problem	25	25
Scratched Material	24	24
Erratic or Intermittent Display	20	20
Material Split, Cut or Torn	16	16
Dent in Material	15	15
Optical Problem	13	13
Crack	13	13
Loose or Intermittent Connection	12	12
Material Discolored	12	12
Output Problem	11	11
Material Integrity Problem	11	11
Failure to Clean Adequately	10	10
Leak/Splash	9	9
Image Orientation Incorrect	9	9
Image Display Error/Artifact	9	9
Contamination	9	9
Fracture	7	7
Defective Component	6	6
Material Deformation	4	4
Connection Problem	4	4
Mechanical Problem	4	4
Defective Device	3	3
Electrical /Electronic Property Problem	3	3
Material Opacification	3	3
Sharp Edges	3	3
Optical Distortion	2	2
Optical Discoloration	2	2
Degraded	2	2
Unintended Movement	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
Flushing Problem	1	1
Fluid/Blood Leak	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
Gas/Air Leak	1	1
Material Fragmentation	1	1
Key or Button Unresponsive/not Working	1	1
Contamination /Decontamination Problem	1	1
Moisture Damage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	586	586
No Known Impact Or Consequence To Patient	6	6
Insufficient Information	4	4
Foreign Body In Patient	1	1