TPLC - Total Product Life Cycle

show TPLC since

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	209	209
No Display/Image	70	70
Communication or Transmission Problem	43	43
Break	36	36
Scratched Material	21	21
Display or Visual Feedback Problem	18	18
Erratic or Intermittent Display	13	13
Material Split, Cut or Torn	12	12
Material Discolored	12	12
Crack	11	11
Optical Problem	11	11
Loose or Intermittent Connection	9	9
Material Integrity Problem	9	9
Contamination	8	8
Image Orientation Incorrect	7	7
Dent in Material	7	7
Leak/Splash	6	6
Output Problem	6	6
Image Display Error/Artifact	5	5
Defective Component	5	5
Mechanical Problem	3	3
Material Opacification	3	3
Defective Device	3	3
Failure to Clean Adequately	3	3
Fracture	3	3
Material Deformation	3	3
Unintended Movement	2	2
Optical Distortion	2	2
Connection Problem	2	2
Detachment of Device or Device Component	2	2
Misfocusing	1	1
Fluid/Blood Leak	1	1
Electrical /Electronic Property Problem	1	1
Corroded	1	1
Optical Obstruction	1	1
Self-Activation or Keying	1	1
Optical Discoloration	1	1
Flushing Problem	1	1
Sharp Edges	1	1
Moisture or Humidity Problem	1	1
Gas/Air Leak	1	1
Material Fragmentation	1	1
Degraded	1	1
Key or Button Unresponsive/not Working	1	1
Contamination /Decontamination Problem	1	1
Moisture Damage	1	1
Electrical Overstress	1	1
Smoking	1	1
Material Puncture/Hole	1	1
Display Difficult to Read	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	457	457
Insufficient Information	3	3
No Known Impact Or Consequence To Patient	1	1
Foreign Body In Patient	1	1