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	177	177
Break	87	87
Unintended Movement	84	84
Material Fragmentation	76	76
Material Separation	73	73
Inflation Problem	52	54
Material Rupture	31	31
Failure to Deflate	30	30
Deflation Problem	21	21
Leak/Splash	14	14
Insufficient Information	12	12
Material Puncture/Hole	11	12
Structural Problem	9	9
Fluid/Blood Leak	8	8
Therapeutic or Diagnostic Output Failure	7	7
Unintended Deflation	7	7
Improper or Incorrect Procedure or Method	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Defective Component	6	6
Fracture	4	4
Material Protrusion/Extrusion	4	4
Gas/Air Leak	4	4
Disconnection	4	4
Physical Resistance/Sticking	4	4
Mechanical Problem	4	4
Entrapment of Device	4	4
Device Fell	3	3
Peeled/Delaminated	3	3
Output Problem	3	4
Difficult to Open or Close	3	3
Material Twisted/Bent	3	3
Melted	3	3
Material Split, Cut or Torn	3	3
Device Markings/Labelling Problem	2	2
Defective Device	2	2
Loss of or Failure to Bond	2	2
Inadequate Instructions for Healthcare Professional	2	4
Contamination /Decontamination Problem	2	2
Human-Device Interface Problem	2	2
Positioning Failure	2	2
Connection Problem	2	2
Use of Device Problem	2	2
Component Missing	2	2
Device Dislodged or Dislocated	2	2
Sharp Edges	2	2
Activation, Positioning or Separation Problem	2	2
Burst Container or Vessel	2	2
Device Contaminated During Manufacture or Shipping	2	2
Device Slipped	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	491	493
Insufficient Information	84	86
No Consequences Or Impact To Patient	52	52
Foreign Body In Patient	49	49
No Known Impact Or Consequence To Patient	34	35
Uterine Perforation	18	18
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
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
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

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