TPLC - Total Product Life Cycle

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Device	cannula, manipulator/injector, uterine
Product Code	LKF
Regulation Number	884.4530
Device Class	2

Premarket Reviews
Manufacturer	Decision
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
	SUBSTANTIALLY EQUIVALENT	1
CATHETER RESEARCH, INC.
	SUBSTANTIALLY EQUIVALENT	1
CLEARPATH SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CLINICAL INNOVATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	5
COOPER SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOPERSURGICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
COOPERSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
CROSSBAY MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDOCONTROL
	SUBSTANTIALLY EQUIVALENT	1
FEMASYS INC.
	SUBSTANTIALLY EQUIVALENT	5
GYNETECH PTY. LTD.
	SUBSTANTIALLY EQUIVALENT	2
KRONNER PROTOTYPES, INC.
	SUBSTANTIALLY EQUIVALENT	1
OBG PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
PANPAC MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
REJONI, INC.
	SUBSTANTIALLY EQUIVALENT	1
STERLING MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
THE O R COMPANY PTY LTD
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	175	175
Break	147	147
Unintended Movement	84	84
Inflation Problem	81	81
Material Separation	79	79
Material Fragmentation	78	78
Detachment Of Device Component	55	55
Material Rupture	32	32
Deflation Problem	24	24
Failure to Deflate	20	20
Material Puncture/Hole	17	17
Insufficient Information	16	16
Leak/Splash	12	12
Improper or Incorrect Procedure or Method	12	12
Component Missing	12	12
Device Operates Differently Than Expected	11	11
Hole In Material	10	10
Structural Problem	10	10
Material Protrusion/Extrusion	8	8
Therapeutic or Diagnostic Output Failure	8	8
Component Falling	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Device Dislodged or Dislocated	7	7
Device Slipped	6	6
Fluid/Blood Leak	6	6
Burst Container or Vessel	6	6
Gas/Air Leak	6	6
Melted	6	6
Difficult to Remove	6	6
Loose or Intermittent Connection	6	6
Material Perforation	5	5
Fracture	5	5
Use of Device Problem	5	5
Human-Device Interface Problem	5	5
Defective Device	5	5
Defective Component	5	5
Unintended Deflation	5	5
Torn Material	5	5
Malposition of Device	5	5
Physical Resistance/Sticking	4	4
Output Problem	4	4
Entrapment of Device	4	4
Disconnection	4	4
Device Or Device Fragments Location Unknown	3	3
Appropriate Term/Code Not Available	3	3
Peeled/Delaminated	3	3
Material Twisted/Bent	3	3
Migration or Expulsion of Device	3	3
Mechanical Problem	3	3
Material Split, Cut or Torn	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	353	353
No Known Impact Or Consequence To Patient	189	189
No Consequences Or Impact To Patient	109	109
Insufficient Information	77	77
Foreign Body In Patient	71	71
Uterine Perforation	23	23
No Code Available	21	21
No Information	21	21
Device Embedded In Tissue or Plaque	12	12
Laceration(s)	9	9
No Patient Involvement	6	6
Injury	5	5
Abdominal Pain	4	4
Perforation	4	4
Hemorrhage/Bleeding	3	3
Bowel Perforation	3	3
Fever	3	3
Abscess	2	2
Pain	2	2
Needle Stick/Puncture	2	2
Obstruction/Occlusion	2	2
Rupture	2	2
Abnormal Vaginal Discharge	2	2
Death	2	2
Foreign Body Reaction	1	1
Pelvic Inflammatory Disease	1	1
Foreign body, removal of	1	1
Adhesion(s)	1	1
Rash	1	1
Test Result	1	1
Discomfort	1	1
Joint Swelling	1	1
Unspecified Gastrointestinal Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Tissue Injury	1	1
Hypoxia	1	1
Tissue Damage	1	1
Skin Tears	1	1
Nonresorbable materials, unretrieved in body	1	1
Unspecified Infection	1	1
Bacterial Infection	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Low Oxygen Saturation	1	1
Air Embolism	1	1
Embolus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Clinical Innovations, LLC	II	May-26-2020
2	Cooper Surgical, Inc.	II	Nov-26-2012
3	CooperSurgical, Inc.	II	Dec-06-2023
4	CooperSurgical, Inc.	II	Jun-08-2015
5	CooperSurgical, Inc.	II	Sep-05-2014
6	CooperSurgical, Inc.	II	Jun-11-2014
7	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022