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	764	1015
Break	388	389
Material Fragmentation	380	380
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
Excessive Heating	26	26
Failure to Cut	26	26
Physical Resistance/Sticking	18	18
Detachment of Device or Device Component	17	17
Tear, Rip or Hole in Device Packaging	17	17
Defective Device	16	16
Material Integrity Problem	15	15
Entrapment of Device	14	14
Material Twisted/Bent	13	13
Packaging Problem	13	13
Separation Problem	12	12
Contamination /Decontamination Problem	10	10
Use of Device Problem	9	9
Material Separation	8	8
Device-Device Incompatibility	8	8
Material Deformation	7	7
Material Disintegration	7	8
Insufficient Information	7	7
Loose or Intermittent Connection	6	6
Contamination	6	6
Continuous Firing	5	5
Improper or Incorrect Procedure or Method	5	5
Output Problem	5	5
No Apparent Adverse Event	5	5
Premature Separation	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Activation Failure	4	4
Patient Device Interaction Problem	4	4
Device Slipped	4	4
Expiration Date Error	4	4
Device Contamination with Chemical or Other Material	4	4
Insufficient Cooling	4	4
Mechanical Problem	4	4
Unsealed Device Packaging	4	4
Nonstandard Device	3	3
Leak/Splash	3	3
Unintended Ejection	3	3
Material Discolored	3	3
Device Damaged by Another Device	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1977	2257
Insufficient Information	237	269
Foreign Body In Patient	98	101
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