TPLC - Total Product Life Cycle

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Device	confocal optical imaging
Regulation Description	Endoscope and accessories.
Definition	Collection of light signals for visualization of cellular microstructures.
Product Code	OWN
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACTIV SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY AMERICA
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	4
LIMIS DEVELOPMENT B.V.
	SUBSTANTIALLY EQUIVALENT	1
MAUNA KEA TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OPTOSURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SAMANTREE MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	1
SMARTSURGN INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
SMARTSURGN, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	3
STRYKER ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
VISIONSENSE, LTD.
	SUBSTANTIALLY EQUIVALENT	2
VPIX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	322	322
Output Problem	253	253
Optical Problem	113	113
Communication or Transmission Problem	113	113
Temperature Problem	105	105
Poor Quality Image	85	85
Electrical /Electronic Property Problem	63	63
Overheating of Device	61	61
Display or Visual Feedback Problem	45	45
Failure to Power Up	44	44
Erratic or Intermittent Display	32	32
Optical Distortion	25	25
Energy Output Problem	23	23
Fogging	22	22
Connection Problem	18	18
No Device Output	17	17
Activation Failure	16	16
Break	16	16
Electrical Power Problem	16	16
Power Problem	14	14
Image Display Error/Artifact	13	13
Excessive Heating	12	12
Insufficient Device Problem Information	12	12
Intermittent Loss of Power	11	11
Unexpected Shutdown	11	11
Electrical Overstress	11	11
Device Sensing Problem	10	10
Defective Component	10	10
Use of Device Problem	9	9
Failure to Shut Off	8	8
Smoking	8	8
Material Integrity Problem	8	8
Circuit Failure	8	8
Adverse Event Without Identified Device or Use Problem	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Dent in Material	5	5
Thermal Decomposition of Device	5	5
Moisture or Humidity Problem	5	5
Component Misassembled	5	5
Material Deformation	5	5
Detachment of Device or Device Component	5	5
Complete Loss of Power	5	5
Optical Obstruction	4	4
Loose or Intermittent Connection	4	4
Fracture	4	4
Loss of Power	4	4
Crack	4	4
Material Twisted/Bent	4	4
Mechanical Problem	4	4
Computer Software Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1235	1235
Insufficient Information	171	172
Burn(s)	49	49
No Consequences Or Impact To Patient	26	26
Superficial (First Degree) Burn	16	16
Electric Shock	6	6
Bowel Perforation	2	2
Abrasion	2	2
No Patient Involvement	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Syncope/Fainting	1	1
Necrosis	1	1
Laceration(s)	1	1
Bone Cement Implantation Syndrome	1	1
Shock	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Oct-25-2024
2	Visionsense, Ltd.	II	Nov-23-2022