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	727	945
Break	364	365
Material Fragmentation	325	325
Mechanical Jam	188	188
Complete Loss of Power	133	133
Delivered as Unsterile Product	65	88
Smoking	50	50
Dull, Blunt	48	48
Device Contaminated During Manufacture or Shipping	28	28
Appropriate Term/Code Not Available	26	26
Excessive Heating	26	26
Failure to Cut	26	26
Overheating of Device	25	25
Tear, Rip or Hole in Device Packaging	17	17
Physical Resistance/Sticking	16	16
Defective Device	16	16
Detachment of Device or Device Component	16	16
Material Integrity Problem	14	14
Packaging Problem	13	13
Entrapment of Device	13	13
Material Twisted/Bent	12	12
Separation Problem	12	12
Contamination /Decontamination Problem	10	10
Use of Device Problem	8	8
Device-Device Incompatibility	8	8
Material Separation	8	8
Insufficient Information	7	7
Material Deformation	7	7
Material Disintegration	6	7
Loose or Intermittent Connection	6	6
Contamination	6	6
Premature Separation	5	5
Output Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Continuous Firing	5	5
Unsealed Device Packaging	4	4
Insufficient Cooling	4	4
Expiration Date Error	4	4
Device Contamination with Chemical or Other Material	4	4
Adverse Event Without Identified Device or Use Problem	4	4
No Apparent Adverse Event	4	4
Patient Device Interaction Problem	4	4
Activation Failure	4	4
Device Slipped	4	4
Unintended Ejection	3	3
Material Discolored	3	3
Nonstandard Device	3	3
Mechanical Problem	3	3
Temperature Problem	3	3
Noise, Audible	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1850	2092
Insufficient Information	225	255
Foreign Body In Patient	85	85
Device Embedded In Tissue or Plaque	15	26
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
Unspecified Infection	3	3
Unspecified Tissue Injury	3	3
Hemorrhage/Bleeding	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