TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
ARTERYFLOW TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CARL ZEISS MEDITEC INC
	SUBSTANTIALLY EQUIVALENT	1
NOVADAQ TECHNOLOGIES ULC (A PART OF STRYKER)
	SUBSTANTIALLY EQUIVALENT	1
ONLUME INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGVISION GMBH
	SUBSTANTIALLY EQUIVALENT	3
SYNAPTIVE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation Failure	1374	1374
Radiation Output Failure	1048	1048
Positioning Failure	407	407
No Display/Image	213	213
Detachment of Device or Device Component	20	20
Unintended System Motion	19	19
Smoking	15	15
Unexpected Shutdown	14	14
No Device Output	12	12
Erratic or Intermittent Display	12	12
Difficult or Delayed Activation	11	11
Failure to Power Up	10	10
Output Problem	8	8
Image Display Error/Artifact	7	7
Insufficient Information	7	7
Display or Visual Feedback Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Device Operational Issue	4	4
Poor Quality Image	4	4
Radiation Underexposure	3	3
Radiation Output Problem	3	3
Break	3	3
Mechanical Jam	3	3
Fire	3	3
Physical Resistance/Sticking	3	3
Device Dislodged or Dislocated	3	3
Unintended Movement	3	3
Computer Software Problem	3	3
Defective Device	3	3
Radiation Overexposure	3	3
Temperature Problem	2	2
Fluid/Blood Leak	2	2
Unexpected/Unintended Radiation Output	2	2
Image Orientation Incorrect	2	2
Appropriate Term/Code Not Available	2	2
Failure to Advance	2	2
No Apparent Adverse Event	2	2
Data Problem	2	2
Difficult or Delayed Positioning	2	2
Key or Button Unresponsive/not Working	2	2
Air/Gas in Device	2	2
Malposition of Device	2	2
Entrapment of Device	2	2
Visual Prompts will not Clear	1	1
Imprecision	1	1
Use of Device Problem	1	1
Gas/Air Leak	1	1
Structural Problem	1	1
Optical Distortion	1	1
Output above Specifications	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3103	3103
Insufficient Information	54	54
No Consequences Or Impact To Patient	9	9
Fall	7	7
No Known Impact Or Consequence To Patient	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pain	4	4
Laceration(s)	3	3
Crushing Injury	2	2
Radiation Overdose	2	2
Hemorrhage/Bleeding	2	2
Brain Injury	1	1
Skull Fracture	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Hematoma	1	1
Obstruction/Occlusion	1	1
Hemorrhagic Stroke	1	1
Cardiac Arrest	1	1
Hair Loss	1	1
Paresis	1	1
Myocardial Infarction	1	1
Skin Tears	1	1
Ruptured Aneurysm	1	1
Low Blood Pressure/ Hypotension	1	1
Bruise/Contusion	1	1