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	2403	2404
Radiation Output Failure	1884	1884
Positioning Failure	751	751
No Display/Image	390	390
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
Difficult or Delayed Activation	13	13
No Device Output	13	13
Erratic or Intermittent Display	13	13
Insufficient Device Problem Information	12	12
Output Problem	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 Output Problem	5	5
Device Dislodged or Dislocated	4	4
Radiation Underexposure	4	4
Break	4	4
Material Integrity Problem	3	3
Mechanical Jam	3	3
Key or Button Unresponsive/not Working	3	3
Fluid/Blood Leak	3	3
Unexpected/Unintended Radiation Output	3	3
No Apparent Adverse Event	3	3
Difficult or Delayed Positioning	3	3
Activation Problem	3	3
Appropriate Device Problem Term/Code Not Available	3	3
Air/Gas in Device	2	2
Device Reprocessing Problem	2	2
Computer Software Problem	2	2
Failure to Advance	2	2
Leak/Splash	2	2
Fire	2	2
Defective Device	2	2
Malposition of Device	2	2
Mechanical Problem	2	2
Loose or Intermittent Connection	2	2
Entrapment of Device	2	3
Optical Distortion	1	1
Use of Incorrect Control/Treatment Settings	1	1
Loss of Data	1	1
Device Slipped	1	1
Structural Problem	1	1
Accessory Incompatible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5573	5574
Insufficient Information	75	75
Unspecified Tissue Injury	9	9
Fall	9	9
Needle Stick/Puncture	6	6
No Consequences Or Impact To Patient	5	5
Cardiac Arrest	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Pain	4	4
Laceration(s)	3	4
Hemorrhage/Blood Loss/Bleeding	3	3
Crushing Injury	2	3
Head Injury	2	2
Paresis	1	1
Low Blood Pressure/ Hypotension	1	1
Ischemia	1	1
Air Embolism	1	1
Hemoptysis	1	1
Myocardial Infarction	1	1
Hemorrhagic Stroke	1	1
Subclinical Infection	1	1
Brain Injury	1	1
Bruise/Contusion	1	1
Abortion	1	1
Neck Pain	1	1
Stroke/CVA	1	1
Damage to Ligament(s)	1	1
Hair Loss	1	1
Nodule	1	1
Bone Fracture(s)	1	1
Obstruction/Occlusion	1	1
Concussion	1	1
Headache	1	1
Gastrointestinal Hemorrhage	1	1
Skull Fracture	1	1
Hemodynamic instability	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