TPLC - Total Product Life Cycle

show TPLC since

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	166	166
Unintended Movement	83	83
Break	79	79
Material Separation	72	72
Material Fragmentation	66	66
Inflation Problem	49	51
Failure to Deflate	30	30
Material Rupture	29	29
Deflation Problem	19	19
Insufficient Information	12	12
Material Puncture/Hole	11	12
Structural Problem	9	9
Leak/Splash	7	7
Unintended Deflation	7	7
Improper or Incorrect Procedure or Method	6	6
Defective Component	6	6
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
Gas/Air Leak	4	4
Melted	3	3
Material Twisted/Bent	3	3
Material Split, Cut or Torn	3	3
Entrapment of Device	3	3
Mechanical Problem	3	3
Output Problem	3	3
Peeled/Delaminated	3	3
Loss of or Failure to Bond	2	2
Difficult to Open or Close	2	2
Human-Device Interface Problem	2	2
Activation, Positioning or Separation 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
Device Markings/Labelling Problem	2	2
Inadequate Instructions for Healthcare Professional	2	4
Device Fell	2	2
Defective Device	2	2
Use of Device Problem	1	1
Material Too Rigid or Stiff	1	1
Positioning Failure	1	1
Material Perforation	1	1
Malposition of Device	1	1
Device Damaged by Another Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	452	454
Insufficient Information	80	81
No Consequences Or Impact To Patient	52	52
Foreign Body In Patient	47	47
No Known Impact Or Consequence To Patient	34	35
Uterine Perforation	17	17
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
Bowel Perforation	1	1
Pelvic Inflammatory Disease	1	1
Pain	1	1
Unspecified Tissue Injury	1	1
Skin Tears	1	1
Bacterial Infection	1	1
Internal Organ Perforation	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