TPLC - Total Product Life Cycle

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Device	blade, saw, general & plastic surgery, surgical
Regulation Description	Surgical instrument motors and accessories/attachments.
Product Code	GFA
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	771	1022
Break	393	394
Material Fragmentation	393	393
Mechanical Jam	196	196
Complete Loss of Power	135	135
Delivered as Unsterile Product	70	98
Dull, Blunt	54	54
Smoking	51	51
Device Contaminated During Manufacture or Shipping	31	31
Overheating of Device	29	29
Appropriate Term/Code Not Available	27	27
Failure to Cut	26	26
Excessive Heating	26	26
Physical Resistance/Sticking	22	22
Tear, Rip or Hole in Device Packaging	17	17
Detachment of Device or Device Component	17	17
Defective Device	16	16
Material Integrity Problem	15	15
Entrapment of Device	14	14
Packaging Problem	13	13
Material Twisted/Bent	13	13
Separation Problem	12	12
Contamination /Decontamination Problem	10	10
Device-Device Incompatibility	9	9
Use of Device Problem	9	9
Material Separation	8	8
Material Deformation	7	7
Material Disintegration	7	8
Insufficient Information	7	7
Contamination	6	6
Loose or Intermittent Connection	6	6
No Apparent Adverse Event	5	5
Unsealed Device Packaging	5	5
Premature Separation	5	5
Output Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Continuous Firing	5	5
Device Contamination with Chemical or Other Material	4	4
Device Damaged by Another Device	4	4
Activation Failure	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Patient Device Interaction Problem	4	4
Expiration Date Error	4	4
Insufficient Cooling	4	4
Mechanical Problem	4	4
Device Slipped	4	4
Material Discolored	3	3
Unintended Ejection	3	3
Nonstandard Device	3	3
Temperature Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2004	2284
Insufficient Information	240	272
Foreign Body In Patient	99	102
Device Embedded In Tissue or Plaque	16	30
Burn(s)	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Laceration(s)	6	6
Pain	6	6
Superficial (First Degree) Burn	5	5
Bone Fracture(s)	5	5
Hemorrhage/Bleeding	5	5
Unspecified Infection	3	3
Unspecified Tissue Injury	3	3
Muscle Weakness	2	2
Anxiety	2	2
Hypersensitivity/Allergic reaction	1	1
Failure of Implant	1	1
Discomfort	1	1
Muscle/Tendon Damage	1	1
Extravasation	1	1
Hypoxia	1	1
Myocardial Infarction	1	1
Tissue Breakdown	1	1
Full thickness (Third Degree) Burn	1	1
Hypovolemia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	MEDLINE INDUSTRIES, LP - Northfield	II	Jan-11-2023