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	2309	2310
Mechanical Jam	1175	1175
Mechanical Problem	482	483
Protective Measures Problem	259	259
Noise, Audible	189	189
Insufficient Information	179	179
Flaked	127	127
Break	126	126
Material Fragmentation	113	113
Physical Resistance/Sticking	70	70
No Apparent Adverse Event	63	63
Electrical /Electronic Property Problem	47	47
Communication or Transmission Problem	47	47
Electrical Shorting	47	47
Detachment of Device or Device Component	45	45
Key or Button Unresponsive/not Working	39	39
Corroded	36	36
Activation Failure	36	36
Self-Activation or Keying	35	35
Unexpected Shutdown	35	35
Material Deformation	33	33
Failure to Power Up	27	27
Adverse Event Without Identified Device or Use Problem	25	25
Output below Specifications	21	21
Connection Problem	15	15
Failure to Shut Off	15	15
Intermittent Energy Output	15	15
Activation Problem	14	14
Unintended Power Up	14	14
Delivered as Unsterile Product	14	14
Smoking	12	12
Fracture	11	11
Material Twisted/Bent	11	11
Packaging Problem	9	9
Device Emits Odor	8	8
Material Integrity Problem	6	6
Melted	5	5
Complete Loss of Power	4	4
Suction Problem	4	4
Appropriate Term/Code Not Available	4	4
Material Separation	4	4
Component Missing	4	4
Device Contaminated During Manufacture or Shipping	4	4
Crack	4	4
Material Discolored	3	3
Unintended Ejection	3	3
Leak/Splash	3	3
Fitting Problem	3	3
Failure to Cut	3	3
Difficult to Insert	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4133	4134
Foreign Body In Patient	40	40
Insufficient Information	21	21
Burn(s)	11	11
Unspecified Infection	3	3
Loss of Range of Motion	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Bone Fracture(s)	2	2
Post Operative Wound Infection	2	2
Pain	2	2
Capsular Contracture	2	2
Partial thickness (Second Degree) Burn	2	2
Hemorrhage/Bleeding	2	2
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