TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTIC GREEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
DIGITAL SURGERY SYSTEMS, INC. (D.B.A TRUE DIGITAL SURGERY)
	SUBSTANTIALLY EQUIVALENT	1
NOVADAQ TECHNOLOGIES ULC (A PART OF STRYKER)
	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	2296	2297
Radiation Output Failure	1832	1832
Positioning Failure	725	725
No Display/Image	380	380
Failure to Power Up	57	57
Unintended System Motion	41	41
Detachment of Device or Device Component	36	36
Smoking	16	16
Unexpected Shutdown	15	15
Output Problem	14	14
No Device Output	13	13
Erratic or Intermittent Display	13	13
Difficult or Delayed Activation	13	13
Image Display Error/Artifact	11	11
Insufficient Information	11	11
Display or Visual Feedback Problem	10	10
Poor Quality Image	7	7
Device Operational Issue	6	6
Radiation Output Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Mechanical Jam	4	4
Break	4	4
Image Orientation Incorrect	4	4
Device Dislodged or Dislocated	4	4
Radiation Underexposure	3	3
Unexpected/Unintended Radiation Output	3	3
Appropriate Term/Code Not Available	3	3
Activation Problem	3	3
Computer Software Problem	3	3
No Apparent Adverse Event	3	3
Material Integrity Problem	3	3
Key or Button Unresponsive/not Working	3	3
Fluid/Blood Leak	2	2
Device Reprocessing Problem	2	2
Failure to Advance	2	2
Data Problem	2	2
Difficult or Delayed Positioning	2	2
Air/Gas in Device	2	2
Defective Device	2	2
Unintended Movement	2	2
Entrapment of Device	2	3
Fire	2	2
Mechanical Problem	2	2
Malposition of Device	2	2
Physical Resistance/Sticking	2	2
Noise, Audible	1	1
Temperature Problem	1	1
Loss of or Failure to Bond	1	1
Leak/Splash	1	1
Failure to Read Input Signal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5365	5366
Insufficient Information	74	74
Fall	9	9
Unspecified Tissue Injury	9	9
Cardiac Arrest	5	5
No Consequences Or Impact To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Needle Stick/Puncture	4	4
Pain	4	4
Laceration(s)	3	4
Hemorrhage/Bleeding	3	3
Crushing Injury	2	3
Air Embolism	1	1
Stroke/CVA	1	1
Brain Injury	1	1
Gastrointestinal Hemorrhage	1	1
Skull Fracture	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Hemoptysis	1	1
Ischemia	1	1
Obstruction/Occlusion	1	1
Hemorrhagic Stroke	1	1
Neck Pain	1	1
Hair Loss	1	1
Paresis	1	1
Nodule	1	1
Myocardial Infarction	1	1
Headache	1	1
Abortion	1	1
Low Blood Pressure/ Hypotension	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Shimadzu Medical Systems	II	Feb-28-2022