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
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	1173	1173
Radiation Output Failure	874	874
Positioning Failure	351	351
No Display/Image	186	186
Unintended System Motion	19	19
Detachment of Device or Device Component	19	19
Smoking	14	14
No Device Output	12	12
Unexpected Shutdown	12	12
Erratic or Intermittent Display	11	11
Difficult or Delayed Activation	11	11
Adverse Event Without Identified Device or Use Problem	9	9
Output Problem	9	9
Failure to Power Up	9	9
Insufficient Information	8	8
Image Display Error/Artifact	7	7
Poor Quality Image	6	6
Display or Visual Feedback Problem	5	5
Unintended Movement	5	5
Noise, Audible	3	3
Mechanical Jam	3	3
Device Dislodged or Dislocated	3	3
Radiation Overexposure	3	3
Defective Device	3	3
Device Fell	3	3
Radiation Underexposure	3	3
Radiation Output Problem	3	3
Break	3	3
Fire	3	3
Device Operational Issue	3	3
Physical Resistance/Sticking	3	3
Failure to Read Input Signal	2	2
Temperature Problem	2	2
Fluid/Blood Leak	2	2
Unexpected/Unintended Radiation Output	2	2
Appropriate Term/Code Not Available	2	2
Failure to Advance	2	2
Computer Software Problem	2	2
Entrapment of Device	2	2
Data Problem	2	2
Difficult or Delayed Positioning	2	2
Malposition of Device	2	2
Use of Device Problem	2	2
Key or Button Unresponsive/not Working	2	2
Air/Gas in Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Communication or Transmission Problem	1	1
Visual Prompts will not Clear	1	1
Component Missing	1	1
Gas/Air Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2631	2631
Insufficient Information	50	50
No Known Impact Or Consequence To Patient	20	20
No Consequences Or Impact To Patient	11	11
Fall	7	7
Laceration(s)	5	5
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	2
Hemorrhage/Bleeding	2	2
Bruise/Contusion	2	2
Brain Injury	1	1
Radiation Exposure, Unintended	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
Injury	1	1
Paresis	1	1
Myocardial Infarction	1	1
Skin Tears	1	1
Ruptured Aneurysm	1	1
Low Blood Pressure/ Hypotension	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