TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
270SURGICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
A.M.I. AGENCY FOR MEDICAL INNOVATIONS GMBH
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	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	2880	2880
No Display/Image	789	789
Communication or Transmission Problem	576	576
Break	575	575
Optical Discoloration	326	326
Dent in Material	253	253
Erratic or Intermittent Display	250	250
Material Split, Cut or Torn	232	232
Crack	201	201
Failure to Cut	183	183
Image Display Error/Artifact	177	177
Scratched Material	157	157
Display or Visual Feedback Problem	146	146
Output Problem	139	139
Leak/Splash	134	134
Optical Problem	131	131
Loose or Intermittent Connection	124	124
Fracture	117	117
Material Integrity Problem	83	83
Material Twisted/Bent	78	78
Image Orientation Incorrect	68	68
Mechanical Problem	59	59
Material Deformation	49	49
Defective Component	47	47
Detachment of Device or Device Component	46	46
Material Puncture/Hole	42	42
Gas/Air Leak	41	41
Connection Problem	36	36
Defective Device	35	35
Dull, Blunt	31	31
Electrical /Electronic Property Problem	28	28
Adverse Event Without Identified Device or Use Problem	23	23
Material Discolored	22	22
Difficult to Open or Close	21	21
Display Difficult to Read	19	19
Unexpected Color	19	19
Contamination	18	18
Fogging	17	17
Mechanical Jam	16	16
Failure to Clean Adequately	15	15
Material Fragmentation	13	13
Electrical Overstress	13	13
No Device Output	12	12
Degraded	12	12
Circuit Failure	12	12
Corroded	11	11
Unintended Movement	11	11
Fluid/Blood Leak	11	11
Moisture or Humidity Problem	10	10
Sharp Edges	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6806	6806
Insufficient Information	41	41
No Consequences Or Impact To Patient	32	32
No Known Impact Or Consequence To Patient	12	12
Foreign Body In Patient	11	11
Bowel Perforation	8	8
Burn(s)	6	6
Unspecified Tissue Injury	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Injury	4	4
Hemorrhage/Bleeding	4	4
Solid Tumour	3	3
No Patient Involvement	3	3
No Code Available	2	2
Adhesion(s)	2	2
Peritonitis	2	2
Pain	2	2
Laceration(s)	2	2
Impaired Healing	1	1
Syncope/Fainting	1	1
Wound Dehiscence	1	1
Arrhythmia	1	1
Not Applicable	1	1
Perforation	1	1
Hemoptysis	1	1
Blood Loss	1	1
Post Operative Wound Infection	1	1
Fever	1	1
Numbness	1	1
Respiratory Tract Infection	1	1
Ecchymosis	1	1
Fluid Discharge	1	1
Tissue Damage	1	1
Headache	1	1
Fibrosis	1	1
Leiomyosarcoma	1	1
Abortion	1	1
Full thickness (Third Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1

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