TPLC - Total Product Life Cycle

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Device	laparoscope, gynecologic (and accessories)
Product Code	HET
Regulation Number	884.1720
Device Class	2

Premarket Reviews
Manufacturer	Decision
270SURGICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
270SURGICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	1
PRECISION ROBOTICS (HONG KONG) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SCHOELLY FIBEROPTIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEJONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Poor Quality Image	1447	1447
No Display/Image	318	318
Break	222	222
Optical Discoloration	219	219
Communication or Transmission Problem	202	202
Failure to Cut	187	187
Image Display Error/Artifact	117	117
Erratic or Intermittent Display	101	101
Crack	92	92
Material Split, Cut or Torn	76	76
Scratched Material	75	75
Display or Visual Feedback Problem	73	73
Dent in Material	58	58
Output Problem	50	50
Loose or Intermittent Connection	49	49
Leak/Splash	41	41
Adverse Event Without Identified Device or Use Problem	40	40
Image Orientation Incorrect	34	34
Defective Component	31	31
Mechanical Problem	30	30
Detachment of Device or Device Component	29	29
Dull, Blunt	29	29
Optical Problem	29	29
Material Integrity Problem	24	24
Defective Device	22	22
Difficult to Open or Close	21	21
Material Puncture/Hole	18	18
Display Difficult to Read	18	18
Unexpected Color	18	18
Electrical /Electronic Property Problem	17	17
Mechanical Jam	15	15
Connection Problem	13	13
Gas/Air Leak	13	13
Fluid/Blood Leak	13	13
Material Deformation	13	13
Fracture	12	12
Material Discolored	12	12
Material Twisted/Bent	12	12
Material Fragmentation	11	11
Circuit Failure	8	8
Moisture or Humidity Problem	6	6
Material Separation	6	6
Contamination	6	6
Optical Obstruction	5	5
Flare or Flash	4	4
Failure to Clean Adequately	4	4
Sparking	4	4
Optical Decentration	4	4
Device Contaminated During Manufacture or Shipping	4	4
Optical Distortion	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3210	3210
No Consequences Or Impact To Patient	44	44
Insufficient Information	22	22
Injury	19	19
No Known Impact Or Consequence To Patient	18	18
No Code Available	13	13
Foreign Body In Patient	10	10
Bowel Perforation	6	6
Burn(s)	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Not Applicable	4	4
Exposure to Body Fluids	4	4
Hemorrhage/Bleeding	3	3
Solid Tumour	3	3
Pain	3	3
No Patient Involvement	3	3
Device Embedded In Tissue or Plaque	2	2
Fibrosis	2	2
Unspecified Tissue Injury	2	2
Laceration(s)	2	2
Adhesion(s)	2	2
Wound Dehiscence	2	2
Post Operative Wound Infection	1	1
Blood Loss	1	1
Fever	1	1
Hemoptysis	1	1
Perforation	1	1
Numbness	1	1
Respiratory Tract Infection	1	1
Abdominal Distention	1	1
Arrhythmia	1	1
Ecchymosis	1	1
Fluid Discharge	1	1
Tissue Damage	1	1
Death	1	1
Cancer	1	1
Syncope/Fainting	1	1
Impaired Healing	1	1
Headache	1	1
Leiomyosarcoma	1	1
Abortion	1	1
Full thickness (Third Degree) Burn	1	1
Abdominal Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-17-2023
2	Carefusion 2200 Inc	II	Mar-30-2022
3	Karl Storz Endoscopy	II	Apr-03-2024
4	Karl Storz Endoscopy	II	Dec-18-2023
5	Olympus Corporation of the Americas	II	Jan-10-2024
6	Olympus Corporation of the Americas	II	Jan-05-2024