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
STRYKER ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
SURGIMAGE CORPORATION
	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	2449	2450
Radiation Output Failure	1916	1916
Positioning Failure	766	766
No Display/Image	397	397
Failure to Power Up	57	57
Unintended System Motion	41	41
Detachment of Device or Device Component	39	39
Smoking	15	15
Unexpected Shutdown	13	13
No Device Output	13	13
Erratic or Intermittent Display	13	13
Difficult or Delayed Activation	13	13
Output Problem	12	12
Insufficient Device Problem Information	12	12
Image Display Error/Artifact	10	10
Display or Visual Feedback Problem	9	9
Device Operational Issue	6	6
Poor Quality Image	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Image Orientation Incorrect	6	6
Radiation Underexposure	5	5
Radiation Output Problem	5	5
Break	4	4
Difficult or Delayed Positioning	4	4
Device Dislodged or Dislocated	4	4
Appropriate Device Problem Term/Code Not Available	3	3
No Apparent Adverse Event	3	3
Fluid/Blood Leak	3	3
Activation Problem	3	3
Unexpected/Unintended Radiation Output	3	3
Material Integrity Problem	3	3
Mechanical Jam	3	3
Key or Button Unresponsive/not Working	3	3
Computer Software Problem	2	2
Failure to Advance	2	2
Device Reprocessing Problem	2	2
Air/Gas in Device	2	2
Loose or Intermittent Connection	2	2
Defective Device	2	2
Malposition of Device	2	2
Mechanical Problem	2	2
Fire	2	2
Entrapment of Device	2	3
Leak/Splash	2	2
Connection Problem	1	1
Complete Loss of Power	1	1
Electrical /Electronic Property Problem	1	1
Flaked	1	1
Improper or Incorrect Procedure or Method	1	1
Inappropriate Audible Prompt/Feedback	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5672	5673
Insufficient Information	75	75
Fall	9	9
Unspecified Tissue Injury	9	9
Needle Stick/Puncture	6	6
Cardiac Arrest	5	5
No Consequences Or Impact To Patient	5	5
Pain	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Head Injury	3	3
Hemorrhage/Blood Loss/Bleeding	3	3
Laceration(s)	3	4
Crushing Injury	2	3
Air Embolism	1	1
Damage to Ligament(s)	1	1
Stroke/CVA	1	1
Subclinical Infection	1	1
Brain Injury	1	1
Gastrointestinal Hemorrhage	1	1
Skull Fracture	1	1
Bone Fracture(s)	1	1
Hemoptysis	1	1
Ischemia	1	1
Obstruction/Occlusion	1	1
Hemorrhagic Stroke	1	1
Neck Pain	1	1
Concussion	1	1
Hair Loss	1	1
Paresis	1	1
Nodule	1	1
Myocardial Infarction	1	1
Hemodynamic instability	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	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	II	Jun-16-2026
2	Shimadzu Medical Systems	II	Feb-28-2022