TPLC - Total Product Life Cycle

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Device	guide, needle, surgical
Regulation Description	Manual surgical instrument for general use.
Product Code	GDF
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	17	18
Difficult to Remove	10	10
Device Contamination with Chemical or Other Material	7	7
Detachment of Device or Device Component	7	7
Device Markings/Labelling Problem	6	6
Improper or Incorrect Procedure or Method	5	5
Material Twisted/Bent	5	5
Image Display Error/Artifact	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Difficult to Insert	4	4
Material Fragmentation	3	3
Migration or Expulsion of Device	2	2
Mechanical Problem	1	1
Failure to Cut	1	1
Difficult to Advance	1	1
Failure to Advance	1	1
Failure to Align	1	1
Failure to Eject	1	1
Mechanics Altered	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47	47
Foreign Body In Patient	9	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	6	6
Insufficient Information	6	7
Pneumothorax	3	3
Urticaria	1	1
Swelling/ Edema	1	1
Reaction to Medicinal Component of Device	1	1
Erythema	1	1
Dry Skin	1	1
Itching Sensation	1	1
Hyperplasia	1	1
Pain	1	1
Perforation of Vessels	1	1
Device Embedded In Tissue or Plaque	1	1