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	2
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	3578	3578
No Display/Image	1008	1008
Communication or Transmission Problem	767	767
Break	729	729
Optical Discoloration	375	375
Erratic or Intermittent Display	352	352
Dent in Material	349	349
Material Split, Cut or Torn	256	256
Crack	226	226
Output Problem	206	206
Image Display Error/Artifact	198	198
Leak/Splash	193	193
Scratched Material	189	189
Failure to Cut	183	183
Display or Visual Feedback Problem	163	163
Optical Problem	157	157
Loose or Intermittent Connection	154	154
Fracture	140	140
Material Twisted/Bent	130	130
Material Integrity Problem	92	92
Gas/Air Leak	76	76
Image Orientation Incorrect	72	72
Mechanical Problem	70	70
Material Deformation	66	66
Detachment of Device or Device Component	62	62
Connection Problem	59	59
Defective Component	52	52
Material Puncture/Hole	46	46
Defective Device	36	36
Electrical /Electronic Property Problem	32	32
Dull, Blunt	31	31
Failure to Clean Adequately	29	29
Unexpected Color	27	27
Adverse Event Without Identified Device or Use Problem	24	24
Material Discolored	23	23
Difficult to Open or Close	22	22
Corroded	22	22
Degraded	22	22
Sharp Edges	21	21
Fogging	21	21
Contamination	21	21
Display Difficult to Read	20	20
No Device Output	20	20
Material Fragmentation	17	17
Mechanical Jam	16	16
Circuit Failure	15	15
Unintended Movement	15	15
Electrical Overstress	14	14
Moisture or Humidity Problem	14	14
Insufficient Heating	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8490	8490
Insufficient Information	50	50
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Unspecified Tissue Injury	6	6
Burn(s)	6	6
Hemorrhage/Bleeding	4	4
Injury	4	4
Solid Tumour	3	3
No Patient Involvement	3	3
Pain	3	3
No Code Available	2	2
Adhesion(s)	2	2
Peritonitis	2	2
Laceration(s)	2	2
Device Embedded In Tissue or Plaque	1	1
Full thickness (Third Degree) Burn	1	1
Abortion	1	1
Leiomyosarcoma	1	1
Fibrosis	1	1
Headache	1	1
Tissue Damage	1	1
Fluid Discharge	1	1
Ecchymosis	1	1
Respiratory Tract Infection	1	1
Numbness	1	1
Fever	1	1
Post Operative Wound Infection	1	1
Blood Loss	1	1
Hemoptysis	1	1
Perforation	1	1
Not Applicable	1	1
Arrhythmia	1	1
Wound Dehiscence	1	1
Unspecified Infection	1	1
Abdominal Pain	1	1
Syncope/Fainting	1	1
Impaired Healing	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