TPLC - Total Product Life Cycle

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Device	motor, drill, pneumatic
Regulation Description	Pneumatic cranial drill motor.
Product Code	HBB
Regulation Number	882.4370
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	582	1026
Detachment of Device or Device Component	458	488
Output below Specifications	178	178
No Apparent Adverse Event	160	160
Material Puncture/Hole	141	141
Fluid/Blood Leak	85	407
Difficult to Insert	76	76
Noise, Audible	72	72
Naturally Worn	60	60
Break	54	53
Vibration	54	54
Physical Resistance/Sticking	43	44
Difficult to Remove	43	43
Unintended System Motion	42	42
Material Twisted/Bent	41	41
Loss of Power	40	40
Fracture	40	40
Excessive Heating	37	37
Complete Loss of Power	32	32
Corroded	30	30
Electrical /Electronic Property Problem	27	27
Burst Container or Vessel	24	35
Device Remains Activated	21	21
Appropriate Term/Code Not Available	17	17
Leak/Splash	16	16
Mechanical Jam	12	12
Unintended Power Up	12	20
Fail-Safe Did Not Operate	11	11
Premature Separation	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Misconnection	10	10
Material Rupture	8	8
Material Deformation	8	8
Material Fragmentation	6	6
Fail-Safe Problem	6	8
Insufficient Information	5	5
Smoking	4	4
Energy Output Problem	4	4
Dull, Blunt	3	3
Device-Device Incompatibility	3	3
Mechanical Problem	3	3
Gas/Air Leak	3	3
Degraded	3	3
Failure to Auto Stop	3	3
Device Reprocessing Problem	2	2
Device Displays Incorrect Message	2	2
Intermittent Loss of Power	2	2
Material Integrity Problem	2	2
Explosion	1	1
Difficult or Delayed Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1620	2412
No Consequences Or Impact To Patient	164	186
No Patient Involvement	35	120
Insufficient Information	21	147
Chemical Exposure	13	13
Burn(s)	13	13
No Known Impact Or Consequence To Patient	11	11
Unintended Radiation Exposure	10	10
Perforation	7	7
Injury	6	6
Unspecified Tissue Injury	6	6
Cerebrospinal Fluid Leakage	6	6
Device Embedded In Tissue or Plaque	6	6
Hearing Impairment	5	5
Unspecified Infection	5	5
Tissue Damage	5	5
Hemorrhage/Bleeding	5	5
Spinal Column Injury	4	4
Nerve Damage	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pain	2	2
Tinnitus	2	2
Spinal Cord Injury	2	2
Muscle Weakness	1	1
Intracranial Hemorrhage	1	1
Oversedation	1	1
Foreign Body In Patient	1	1
Numbness	1	1
Awareness during Anaesthesia	1	1
Laceration(s)	1	1
Reaction	1	1
Partial thickness (Second Degree) Burn	1	3
Headache	1	1