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	1924	1924
Vibration	602	602
Overheating of Device	478	478
Device Damaged by Another Device	438	438
Detachment of Device or Device Component	301	301
Complete Loss of Power	264	264
Unintended System Motion	253	253
Device Alarm System	203	203
Noise, Audible	187	187
Break	165	165
Device-Device Incompatibility	151	151
Fail-Safe Did Not Operate	129	129
Appropriate Term/Code Not Available	114	114
Material Fragmentation	110	110
Mechanical Jam	59	59
Material Frayed	49	49
Separation Problem	46	46
Leak/Splash	41	41
Output below Specifications	38	38
Difficult or Delayed Separation	35	35
Fail-Safe Problem	34	34
Premature Separation	31	31
No Apparent Adverse Event	26	26
Device Slipped	24	24
Mechanical Problem	23	23
Loss of Power	18	18
Environmental Particulates	16	16
Electrical /Electronic Property Problem	14	14
Corroded	14	14
Device Reprocessing Problem	14	14
Difficult to Insert	12	12
Fluid/Blood Leak	11	11
Component Missing	10	10
Intermittent Loss of Power	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Device Remains Activated	7	7
Dull, Blunt	7	7
Physical Resistance/Sticking	7	7
Device Markings/Labelling Problem	7	7
Difficult to Remove	6	6
Device Displays Incorrect Message	6	6
Naturally Worn	6	6
Connection Problem	6	6
Unintended Movement	6	6
Material Integrity Problem	5	5
Separation Failure	5	5
Power Problem	5	5
Fracture	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Material Deformation	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3166	3166
No Consequences Or Impact To Patient	1114	1114
No Known Impact Or Consequence To Patient	44	44
Insufficient Information	26	26
Burn(s)	13	13
Unspecified Tissue Injury	5	5
Brain Injury	3	3
Burn, Thermal	3	3
Full thickness (Third Degree) Burn	3	3
Superficial (First Degree) Burn	2	2
Perforation	2	2
Injury	2	2
Foreign Body In Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Chemical Exposure	1	1
Post Traumatic Wound Infection	1	1
Peroneal Nerve Palsy	1	1
Aneurysm	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1

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