TPLC - Total Product Life Cycle

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Device	motor, drill, electric
Regulation Description	Electric cranial drill motor.
Product Code	HBC
Regulation Number	882.4360
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Excessive Heating	1955	1956
Overheating of Device	714	715
Vibration	604	604
Device Damaged by Another Device	447	447
Detachment of Device or Device Component	325	325
Complete Loss of Power	268	268
Unintended System Motion	254	254
Device Alarm System	204	204
Noise, Audible	194	194
Break	170	170
Device-Device Incompatibility	153	153
Fail-Safe Did Not Operate	129	129
Appropriate Term/Code Not Available	117	117
Material Fragmentation	112	112
Mechanical Jam	61	61
Material Frayed	49	49
Separation Problem	48	48
Leak/Splash	41	41
Output below Specifications	38	38
Difficult or Delayed Separation	38	38
Fail-Safe Problem	34	34
Premature Separation	32	32
No Apparent Adverse Event	32	32
Loss of Power	31	31
Corroded	30	30
Device Remains Activated	25	25
Device Slipped	24	24
Difficult to Insert	23	23
Mechanical Problem	23	23
Environmental Particulates	16	16
Device Displays Incorrect Message	14	14
Electrical /Electronic Property Problem	14	14
Device Reprocessing Problem	14	14
Fluid/Blood Leak	12	12
Naturally Worn	12	12
Component Missing	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Dull, Blunt	8	8
Difficult to Remove	8	8
Intermittent Loss of Power	8	8
Physical Resistance/Sticking	8	8
Material Integrity Problem	7	7
Unintended Movement	7	7
Connection Problem	7	7
Device Markings/Labelling Problem	7	7
Material Rupture	5	5
Separation Failure	5	5
Power Problem	5	5
Fracture	5	5
Manufacturing, Packaging or Shipping Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3500	3501
No Consequences Or Impact To Patient	1114	1114
Insufficient Information	68	69
No Known Impact Or Consequence To Patient	44	44
Burn(s)	16	16
Unspecified Tissue Injury	5	5
Superficial (First Degree) Burn	4	4
Brain Injury	3	3
Burn, Thermal	3	3
Foreign Body In Patient	3	3
Hemorrhage/Bleeding	3	3
Full thickness (Third Degree) Burn	3	3
Speech Disorder	2	2
Perforation	2	2
Chemical Exposure	2	2
Injury	2	2
Convulsion/Seizure	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Infection	1	1
No Code Available	1	1
Post Traumatic Wound Infection	1	1
Post Operative Wound Infection	1	1
Paresthesia	1	1
Oversedation	1	1
Fever	1	1
Burning Sensation	1	1
Erythema	1	1
Peroneal Nerve Palsy	1	1
Pain	1	1
Tissue Damage	1	1
Aneurysm	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	The Anspach Effort, Inc.	II	Jan-07-2023