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	1398	1399
Overheating of Device	700	701
Device Damaged by Another Device	323	323
Vibration	314	314
Complete Loss of Power	262	262
Detachment of Device or Device Component	243	243
Noise, Audible	191	191
Break	165	165
Device-Device Incompatibility	150	150
Unintended System Motion	128	128
Device Alarm System	117	117
Appropriate Term/Code Not Available	116	116
Material Fragmentation	85	85
Fail-Safe Did Not Operate	76	76
Mechanical Jam	56	56
Separation Problem	48	48
Material Frayed	45	45
Difficult or Delayed Separation	39	39
No Apparent Adverse Event	36	36
Loss of Power	34	34
Corroded	32	32
Fail-Safe Problem	31	31
Premature Separation	30	30
Output below Specifications	27	27
Device Remains Activated	25	25
Device Slipped	23	23
Difficult to Insert	23	23
Leak/Splash	20	20
Environmental Particulates	17	17
Mechanical Problem	15	15
Device Displays Incorrect Message	14	14
Electrical /Electronic Property Problem	14	14
Device Reprocessing Problem	14	14
Naturally Worn	12	12
Difficult to Remove	11	11
Component Missing	11	11
Fluid/Blood Leak	11	11
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
Material Integrity Problem	8	8
Dull, Blunt	7	7
Device Markings/Labelling Problem	7	7
Connection Problem	6	6
Unintended Movement	6	6
Material Rupture	5	5
Separation Failure	5	5
Power Problem	5	5
Material Deformation	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3395	3396
Insufficient Information	72	73
Burn(s)	12	12
Unspecified Tissue Injury	5	5
Superficial (First Degree) Burn	4	4
Brain Injury	4	4
Foreign Body In Patient	3	3
Hemorrhage/Bleeding	3	3
Full thickness (Third Degree) Burn	3	3
Speech Disorder	2	2
Chemical Exposure	2	2
Convulsion/Seizure	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Infection	1	1
Nicks, cuts or tears of dura or other tissues by device	1	1
Perforation	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
Numbness	1	1
Pain	1	1
Bruise/Contusion	1	1

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