TPLC - Total Product Life Cycle

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Device	saw, powered, and accessories
Regulation Description	Surgical instrument motors and accessories/attachments.
Product Code	HAB
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	2401	2402
Mechanical Jam	1192	1192
Mechanical Problem	493	494
Protective Measures Problem	259	259
Noise, Audible	192	192
Insufficient Device Problem Information	179	179
Flaked	134	134
Break	131	131
Material Fragmentation	131	131
Physical Resistance/Sticking	82	82
No Apparent Adverse Event	62	62
Electrical /Electronic Property Problem	61	61
Electrical Shorting	50	50
Detachment of Device or Device Component	48	48
Communication or Transmission Problem	48	48
Self-Activation or Keying	44	44
Key or Button Unresponsive/not Working	42	42
Activation Failure	41	41
Unexpected Shutdown	38	38
Corroded	36	36
Material Deformation	35	35
Failure to Power Up	27	27
Adverse Event Without Identified Device or Use Problem	25	25
Output below Specifications	22	22
Failure to Shut Off	19	19
Intermittent Energy Output	19	19
Connection Problem	16	16
Activation Problem	15	15
Delivered as Unsterile Product	15	15
Material Twisted/Bent	15	15
Unintended Power Up	14	14
Fracture	13	13
Smoking	11	11
Packaging Problem	9	9
Device Emits Odor	8	8
Material Integrity Problem	6	6
Melted	6	6
Device Alarm System	5	5
Component Missing	4	4
Suction Problem	4	4
Complete Loss of Power	4	4
Appropriate Device Problem Term/Code Not Available	4	4
Crack	4	4
Device Contaminated During Manufacture or Shipping	4	4
Material Separation	4	4
Device Dislodged or Dislocated	3	3
Material Discolored	3	3
Unintended Ejection	3	3
Power Problem	3	3
Difficult to Insert	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4288	4289
Foreign Body In Patient	42	42
Insufficient Information	22	22
Burn(s)	13	13
Unspecified Infection	3	3
Loss of Range of Motion	3	3
Bone Fracture(s)	2	2
Post Operative Wound Infection	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Pain	2	2
Capsular Contracture	2	2
Partial thickness (Second Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Superficial (First Degree) Burn	1	1
Metal Related Pathology	1	1
No Information	1	1
Unspecified Musculoskeletal problem	1	1
Adhesion(s)	1	1
Hematoma	1	1
Inflammation	1	1
Rupture	1	1
Blister	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Scar Tissue	1	1
Eye Injury	1	1
Forced Expiratory Volume Decreased	1	1
Unspecified Tissue Injury	1	1
Fibrosis	1	1
Full thickness (Third Degree) Burn	1	1
Bruise/Contusion	1	1
Device Embedded In Tissue or Plaque	1	1