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	2120	2121
Radiation Output Failure	1699	1699
Positioning Failure	666	666
No Display/Image	361	361
Unintended System Motion	37	37
Detachment of Device or Device Component	34	34
Failure to Power Up	31	31
Smoking	16	16
Unexpected Shutdown	15	15
No Device Output	13	13
Erratic or Intermittent Display	13	13
Difficult or Delayed Activation	13	13
Output Problem	12	12
Insufficient Information	11	11
Display or Visual Feedback Problem	10	10
Image Display Error/Artifact	8	8
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
Device Dislodged or Dislocated	4	4
Break	4	4
Mechanical Jam	3	3
Appropriate Term/Code Not Available	3	3
Computer Software Problem	3	3
Key or Button Unresponsive/not Working	3	3
Material Integrity Problem	3	3
Radiation Underexposure	3	3
Activation Problem	3	3
Unintended Movement	2	2
Defective Device	2	2
Fluid/Blood Leak	2	2
Unexpected/Unintended Radiation Output	2	2
Air/Gas in Device	2	2
Image Orientation Incorrect	2	2
Physical Resistance/Sticking	2	2
Device Reprocessing Problem	2	2
Malposition of Device	2	2
Difficult or Delayed Positioning	2	2
Data Problem	2	2
Failure to Advance	2	2
Mechanical Problem	2	2
No Apparent Adverse Event	2	2
Fire	2	2
Entrapment of Device	2	3
Noise, Audible	1	1
Temperature Problem	1	1
Loss of or Failure to Bond	1	1
Intermittent Loss of Power	1	1
Loss of Data	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4954	4955
Insufficient Information	72	72
Fall	6	6
Unspecified Tissue Injury	6	6
No Consequences Or Impact To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pain	4	4
Cardiac Arrest	3	3
Laceration(s)	3	4
Crushing Injury	2	3
Needle Stick/Puncture	2	2
Hemorrhage/Bleeding	2	2
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
Ischemia	1	1
Obstruction/Occlusion	1	1
Hemorrhagic Stroke	1	1
Neck Pain	1	1
Hair Loss	1	1
Paresis	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