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	131	131
Unintended Movement	84	84
Break	68	68
Material Fragmentation	61	61
Inflation Problem	39	40
Material Separation	31	31
Material Rupture	31	31
Failure to Deflate	30	30
Deflation Problem	18	18
Leak/Splash	13	13
Insufficient Information	12	12
Structural Problem	9	9
Fluid/Blood Leak	8	8
Material Puncture/Hole	8	8
Unintended Deflation	7	7
Defective Component	6	6
Therapeutic or Diagnostic Output Failure	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Improper or Incorrect Procedure or Method	4	4
Fracture	4	4
Mechanical Problem	4	4
Material Protrusion/Extrusion	4	4
Disconnection	3	3
Melted	3	3
Entrapment of Device	3	3
Peeled/Delaminated	3	3
Material Twisted/Bent	3	3
Difficult to Open or Close	2	2
Connection Problem	2	2
Device Dislodged or Dislocated	2	2
Sharp Edges	2	2
Gas/Air Leak	2	2
Use of Device Problem	2	2
Positioning Failure	2	2
Device Fell	2	2
Output Problem	2	3
Device Contaminated During Manufacture or Shipping	2	2
Activation, Positioning or Separation Problem	2	2
Fail-Safe Problem	1	1
Unraveled Material	1	1
Material Too Rigid or Stiff	1	1
Difficult to Insert	1	1
Contamination /Decontamination Problem	1	1
Inadequate Instructions for Healthcare Professional	1	3
Contamination	1	1
Mechanics Altered	1	1
Failure to Clean Adequately	1	3
Material Integrity Problem	1	1
Defective Device	1	1
Smoking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	467	469
Insufficient Information	79	81
Foreign Body In Patient	43	43
Uterine Perforation	18	18
Laceration(s)	8	8
No Consequences Or Impact To Patient	5	5
Hemorrhage/Bleeding	4	4
Abnormal Vaginal Discharge	2	2
Perforation	2	2
Needle Stick/Puncture	2	2
Perforation of Vessels	2	2
Internal Organ Perforation	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
Unspecified Gastrointestinal Problem	1	1
Bowel Perforation	1	1
No Information	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	CooperSurgical, Inc.	II	Dec-06-2023
2	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022