TPLC - Total Product Life Cycle

show TPLC since

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	1404	1405
Overheating of Device	697	697
Device Damaged by Another Device	325	325
Vibration	312	312
Complete Loss of Power	261	261
Detachment of Device or Device Component	252	252
Noise, Audible	190	190
Break	164	164
Device-Device Incompatibility	153	153
Unintended System Motion	127	127
Device Alarm System	117	117
Appropriate Device Problem Term/Code Not Available	116	116
Material Fragmentation	84	84
Fail-Safe Did Not Operate	76	76
Mechanical Jam	56	56
Separation Problem	47	47
Material Frayed	45	45
Difficult or Delayed Separation	39	39
Loss of Power	37	37
No Apparent Adverse Event	37	37
Corroded	33	33
Fail-Safe Problem	31	31
Premature Separation	29	29
Output below Specifications	26	26
Device Remains Activated	25	25
Difficult to Insert	23	23
Device Slipped	23	23
Leak/Splash	20	20
Environmental Particulates	18	18
Device Displays Incorrect Message	15	15
Mechanical Problem	15	15
Electrical /Electronic Property Problem	14	14
Device Reprocessing Problem	13	13
Naturally Worn	12	12
Difficult to Remove	11	11
Material Integrity Problem	10	10
Component Missing	10	10
Fluid/Blood Leak	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Device Sensing Problem	9	9
Intermittent Loss of Power	8	8
Physical Resistance/Sticking	8	8
Dull, Blunt	7	7
Device Markings/Labelling Problem	7	7
Connection Problem	6	6
Unintended Movement	5	5
Separation Failure	5	5
Power Problem	5	5
Material Rupture	5	5
Fracture	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3419	3420
Insufficient Information	73	74
Burn(s)	15	15
Unspecified Tissue Injury	6	6
Superficial (First Degree) Burn	4	4
Brain Injury	4	4
Foreign Body In Patient	4	4
Hemorrhage/Blood Loss/Bleeding	3	3
Full thickness (Third Degree) Burn	3	3
Speech Disorder	2	2
Chemical Exposure	2	2
Dural Tear	2	2
Partial thickness (Second Degree) Burn	2	2
Convulsion/Seizure	2	2
Unspecified Infection	1	1
Perforation	1	1
Post Operative Wound Infection	1	1
Paresthesia	1	1
Fever	1	1
Oversedation	1	1
Burning Sensation	1	1
Wound Infection	1	1
Erythema	1	1
Numbness	1	1
Pain	1	1
Bruise/Contusion	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1

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