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	1
ACTIV SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY AMERICA
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY_AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	2
KARL STORZ-ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MAUNA KEA TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	4
NOVADAQ TECHNOLOGIES ULC (NOW 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
OPTOSURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
SAMANTREE MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	1
SMARTSURGN INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	3
VISIONSENSE LTD.
	SUBSTANTIALLY EQUIVALENT	2
WUXI HISKY MEDICAL TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	349	349
Output Problem	270	270
Communication or Transmission Problem	120	120
Temperature Problem	113	113
Optical Problem	100	100
Poor Quality Image	96	96
Electrical /Electronic Property Problem	80	80
Failure to Power Up	46	46
Display or Visual Feedback Problem	35	36
Erratic or Intermittent Display	35	35
Overheating of Device	28	28
Thermal Decomposition of Device	21	21
Energy Output Problem	21	21
Adverse Event Without Identified Device or Use Problem	20	20
Break	19	19
Fogging	18	18
Insufficient Information	16	16
Power Problem	13	13
Electrical Power Problem	13	13
No Device Output	13	13
Material Integrity Problem	12	12
Excessive Heating	11	11
Image Display Error/Artifact	11	11
Connection Problem	11	11
Electrical Overstress	11	11
Use of Device Problem	11	11
Device Sensing Problem	10	10
Failure to Shut Off	10	10
Defective Component	10	10
Smoking	9	9
Intermittent Loss of Power	9	9
Activation Failure	8	8
Unexpected Shutdown	8	8
Optical Distortion	7	7
Optical Obstruction	6	6
Loss of Power	6	6
Computer Software Problem	5	5
Component Misassembled	5	5
Detachment of Device or Device Component	5	5
Environmental Compatibility Problem	5	5
Moisture or Humidity Problem	5	5
Circuit Failure	5	5
Therapeutic or Diagnostic Output Failure	5	5
Contamination /Decontamination Problem	4	4
Material Twisted/Bent	4	4
Defective Device	4	4
Misfocusing	4	4
Electro-Static Discharge	4	4
Loose or Intermittent Connection	4	4
Mechanical Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1077	1077
Insufficient Information	163	164
No Consequences Or Impact To Patient	73	73
No Known Impact Or Consequence To Patient	42	42
Burn(s)	39	39
Superficial (First Degree) Burn	14	14
Electric Shock	6	6
No Patient Involvement	6	6
Burn, Thermal	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Bowel Perforation	2	2
Abrasion	2	2
Syncope/Fainting	1	1
Necrosis	1	1
Laceration(s)	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