TPLC - Total Product Life Cycle

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Device	cannula, manipulator/injector, uterine
Regulation Description	Obstetric-gynecologic specialized manual instrument.
Product Code	LKF
Regulation Number	884.4530
Device Class	2

Premarket Reviews
Manufacturer	Decision
COOPERSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K223064 ALLY II Uterine Positioning System™ (UPS)
FEMASYS INC.
	SUBSTANTIALLY EQUIVALENT	2
LI MEDICAL CORPORATION LTD.
	SUBSTANTIALLY EQUIVALENT	1
REJONI, 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	155	155
Unintended Movement	83	83
Break	69	69
Material Separation	68	68
Material Fragmentation	63	63
Inflation Problem	43	43
Failure to Deflate	29	29
Material Rupture	29	29
Deflation Problem	18	18
Material Puncture/Hole	11	11
Insufficient Information	11	11
Structural Problem	9	9
Unintended Deflation	7	7
Improper or Incorrect Procedure or Method	6	6
Leak/Splash	5	5
Fluid/Blood Leak	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Therapeutic or Diagnostic Output Failure	5	5
Disconnection	4	4
Fracture	4	4
Material Protrusion/Extrusion	4	4
Physical Resistance/Sticking	4	4
Melted	3	3
Material Twisted/Bent	3	3
Gas/Air Leak	3	3
Defective Component	3	3
Peeled/Delaminated	3	3
Output Problem	3	3
Material Split, Cut or Torn	3	3
Mechanical Problem	3	3
Entrapment of Device	3	3
Defective Device	2	2
Loss of or Failure to Bond	2	2
Device Fell	2	2
Device Markings/Labelling Problem	2	2
Difficult to Open or Close	2	2
Human-Device Interface Problem	2	2
Component Missing	2	2
Device Dislodged or Dislocated	2	2
Device Contaminated During Manufacture or Shipping	2	2
Sharp Edges	2	2
Burst Container or Vessel	2	2
Device Slipped	1	1
Unstable	1	1
Loose or Intermittent Connection	1	1
Electrical /Electronic Property Problem	1	1
Fitting Problem	1	1
Connection Problem	1	1
Activation, Positioning or Separation Problem	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	418	418
Insufficient Information	79	79
No Consequences Or Impact To Patient	52	52
Foreign Body In Patient	41	41
No Known Impact Or Consequence To Patient	34	34
Uterine Perforation	14	14
Laceration(s)	8	8
Hemorrhage/Bleeding	5	5
No Information	3	3
Abnormal Vaginal Discharge	2	2
Perforation	2	2
Rupture	2	2
Needle Stick/Puncture	2	2
Perforation of Vessels	2	2
Device Embedded In Tissue or Plaque	2	2
Abdominal Pain	1	1
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Unspecified Gastrointestinal Problem	1	1
Pelvic Inflammatory Disease	1	1
Pain	1	1
Unspecified Tissue Injury	1	1
Skin Tears	1	1
Bacterial Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Clinical Innovations, LLC	II	May-26-2020
2	CooperSurgical, Inc.	II	Dec-06-2023
3	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022