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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	154	154
Unintended Movement	83	83
Material Separation	67	67
Break	67	67
Material Fragmentation	61	61
Inflation Problem	41	41
Material Rupture	29	29
Failure to Deflate	28	28
Deflation Problem	18	18
Insufficient Information	11	11
Material Puncture/Hole	11	11
Structural Problem	9	9
Unintended Deflation	6	6
Fluid/Blood Leak	5	5
Leak/Splash	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Therapeutic or Diagnostic Output Failure	5	5
Improper or Incorrect Procedure or Method	4	4
Fracture	4	4
Material Protrusion/Extrusion	4	4
Disconnection	4	4
Physical Resistance/Sticking	4	4
Peeled/Delaminated	3	3
Defective Component	3	3
Melted	3	3
Output Problem	3	3
Material Split, Cut or Torn	3	3
Entrapment of Device	3	3
Mechanical Problem	3	3
Material Twisted/Bent	3	3
Gas/Air Leak	3	3
Loss of or Failure to Bond	2	2
Difficult to Open or Close	2	2
Human-Device Interface Problem	2	2
Device Dislodged or Dislocated	2	2
Device Contaminated During Manufacture or Shipping	2	2
Burst Container or Vessel	2	2
Sharp Edges	2	2
Component Missing	2	2
Defective Device	2	2
Device Fell	2	2
Device Markings/Labelling Problem	2	2
Use of Device Problem	1	1
Material Perforation	1	1
Material Too Rigid or Stiff	1	1
Device Damaged by Another Device	1	1
Mechanics Altered	1	1
Fail-Safe Problem	1	1
Difficult to Insert	1	1
Use of Incorrect Control/Treatment Settings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	408	408
Insufficient Information	79	79
No Consequences Or Impact To Patient	52	52
Foreign Body In Patient	39	39
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
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
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