TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
COOPERSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
REJONI, INC.
	SUBSTANTIALLY EQUIVALENT	1
THE O R COMPANY PTY LTD
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	76	76
2020	119	119
2021	188	188
2022	101	101
2023	88	88
2024	33	33

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	141	141
Unintended Movement	83	83
Break	78	78
Material Separation	63	63
Inflation Problem	56	56
Material Fragmentation	53	53
Material Rupture	30	30
Deflation Problem	21	21
Material Puncture/Hole	15	15
Failure to Deflate	14	14
Structural Problem	10	10
Leak/Splash	10	10
Therapeutic or Diagnostic Output Failure	8	8
Gas/Air Leak	6	6
Insufficient Information	6	6
Unintended Deflation	5	5
Material Protrusion/Extrusion	5	5
Fluid/Blood Leak	5	5
Component Missing	5	5
Defective Device	4	4
Fracture	4	4
Disconnection	4	4
Defective Component	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Human-Device Interface Problem	4	4
Physical Resistance/Sticking	4	4
Material Split, Cut or Torn	3	3
Output Problem	3	3
Material Twisted/Bent	3	3
Burst Container or Vessel	3	3
Entrapment of Device	3	3
Loose or Intermittent Connection	3	3
Mechanical Problem	3	3
Melted	3	3
Malposition of Device	3	3
Improper or Incorrect Procedure or Method	3	3
Use of Device Problem	2	2
Peeled/Delaminated	2	2
Loss of or Failure to Bond	2	2
Device Markings/Labelling Problem	2	2
Difficult to Open or Close	2	2
Device Dislodged or Dislocated	2	2
Sharp Edges	2	2
Device Fell	2	2
Separation Problem	1	1
Appropriate Term/Code Not Available	1	1
Fail-Safe Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Device Damaged by Another Device	1	1
Mechanics Altered	1	1
Pressure Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Electrical /Electronic Property Problem	1	1
Difficult to Insert	1	1
Inadequate Instructions for Healthcare Professional	1	1
Migration or Expulsion of Device	1	1
Difficult to Remove	1	1
Material Too Rigid or Stiff	1	1
Device Slipped	1	1
Smoking	1	1
Unstable	1	1
Fitting Problem	1	1
Material Perforation	1	1
Residue After Decontamination	1	1
Tear, Rip or Hole in Device Packaging	1	1
Contamination /Decontamination Problem	1	1
Activation, Positioning or Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	312	312
No Known Impact Or Consequence To Patient	83	83
Insufficient Information	75	75
No Consequences Or Impact To Patient	71	71
Foreign Body In Patient	30	30
Uterine Perforation	15	15
Laceration(s)	6	6
No Information	5	5
Hemorrhage/Bleeding	3	3
Perforation	2	2
Rupture	2	2
Needle Stick/Puncture	2	2
Skin Tears	1	1
Bowel Perforation	1	1
Injury	1	1
No Code Available	1	1
Unspecified Gastrointestinal Problem	1	1
Unspecified Tissue Injury	1	1
Abnormal Vaginal Discharge	1	1
Pain	1	1
Pelvic Inflammatory Disease	1	1
Abdominal Pain	1	1
Bacterial Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Device Embedded In Tissue or Plaque	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