TPLC - Total Product Life Cycle

show TPLC since

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
NOVADAQ TECHNOLOGIES ULC. (NOW A PART OF STRYKER)
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	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	2065	2066
Radiation Output Failure	1659	1659
Positioning Failure	644	644
No Display/Image	357	357
Unintended System Motion	37	37
Detachment of Device or Device Component	36	36
Failure to Power Up	22	22
Smoking	20	20
Unexpected Shutdown	15	15
No Device Output	13	13
Erratic or Intermittent Display	13	13
Difficult or Delayed Activation	13	13
Insufficient Information	12	12
Display or Visual Feedback Problem	10	10
Output Problem	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Poor Quality Image	9	9
Image Display Error/Artifact	8	8
Device Operational Issue	7	7
Radiation Output Problem	5	5
Unintended Movement	5	5
Device Dislodged or Dislocated	4	4
Break	4	4
Fire	4	4
Computer Software Problem	3	3
Appropriate Term/Code Not Available	3	3
Key or Button Unresponsive/not Working	3	3
Radiation Underexposure	3	3
Mechanical Jam	3	3
Radiation Overexposure	3	3
Defective Device	3	3
Device Fell	3	3
Activation Problem	3	3
Noise, Audible	3	3
Physical Resistance/Sticking	3	3
Entrapment of Device	2	3
Material Integrity Problem	2	2
Unexpected/Unintended Radiation Output	2	2
Therapeutic or Diagnostic Output Failure	2	2
Fluid/Blood Leak	2	2
Failure to Read Input Signal	2	2
Temperature Problem	2	2
Air/Gas in Device	2	2
Malposition of Device	2	2
Image Orientation Incorrect	2	2
Use of Device Problem	2	2
Failure to Advance	2	2
Difficult or Delayed Positioning	2	2
Data Problem	2	2
No Apparent Adverse Event	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4828	4829
Insufficient Information	72	72
No Known Impact Or Consequence To Patient	20	20
No Consequences Or Impact To Patient	11	11
Fall	7	7
Laceration(s)	5	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Hair Loss	4	4
Pain	4	4
No Code Available	3	3
Radiation Overdose	3	3
Death	2	2
Crushing Injury	2	3
Cardiac Arrest	2	2
Hemorrhage/Bleeding	2	2
Bruise/Contusion	2	2
Radiation Exposure, Unintended	1	1
Brain Injury	1	1
Skull Fracture	1	1
Hematoma	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Hemorrhagic Stroke	1	1
Obstruction/Occlusion	1	1
Injury	1	1
Needle Stick/Puncture	1	1
Paresis	1	1
Skin Tears	1	1
Myocardial Infarction	1	1
Low Blood Pressure/ Hypotension	1	1
Abortion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	GE Healthcare, LLC	II	Apr-18-2019
2	Philips Medical Systems Nederlands	II	Apr-13-2019
3	Philips North America, LLC	II	Mar-13-2020
4	Philips North America, LLC	II	Mar-23-2019
5	Shimadzu Medical Systems	II	Feb-28-2022
6	Shimadzu Medical Systems	II	Dec-10-2020
7	Shimadzu Medical Systems Usa Com	II	Feb-27-2019
8	Siemens Medical Solutions USA, Inc	II	May-15-2019