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	950	1465
Detachment of Device or Device Component	658	701
No Apparent Adverse Event	209	210
Output below Specifications	179	179
Material Puncture/Hole	142	142
Difficult to Insert	114	114
Naturally Worn	103	103
Noise, Audible	102	102
Fluid/Blood Leak	95	441
Vibration	76	76
Break	69	68
Fracture	62	62
Physical Resistance/Sticking	57	58
Loss of Power	56	56
Difficult to Remove	54	54
Unintended System Motion	47	47
Material Twisted/Bent	43	43
Excessive Heating	40	40
Device Remains Activated	38	38
Corroded	34	34
Complete Loss of Power	34	34
Electrical /Electronic Property Problem	29	29
Burst Container or Vessel	27	38
Fail-Safe Did Not Operate	23	23
Appropriate Term/Code Not Available	20	20
Leak/Splash	17	17
Adverse Event Without Identified Device or Use Problem	15	15
Product Quality Problem	13	13
Mechanical Jam	13	13
Unintended Power Up	12	20
Premature Separation	11	11
Smoking	10	10
Misconnection	10	10
Material Rupture	10	10
Material Deformation	10	10
Fail-Safe Problem	9	12
Device Displays Incorrect Message	9	9
Material Fragmentation	6	6
Insufficient Information	5	5
Gas/Air Leak	4	4
Energy Output Problem	4	4
Device-Device Incompatibility	4	4
Dull, Blunt	3	3
Degraded	3	3
Material Integrity Problem	3	3
Failure to Auto Stop	3	3
Mechanical Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Explosion	2	2
Device Reprocessing Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2307	3207
No Consequences Or Impact To Patient	164	186
Insufficient Information	112	248
No Patient Involvement	35	120
Burn(s)	15	15
Unintended Radiation Exposure	15	16
Chemical Exposure	13	13
No Known Impact Or Consequence To Patient	11	11
Unspecified Infection	9	9
Device Embedded In Tissue or Plaque	9	9
Perforation	8	8
Injury	6	6
Unspecified Tissue Injury	6	6
Cerebrospinal Fluid Leakage	6	6
Hearing Impairment	5	5
Nerve Damage	5	5
Tissue Damage	5	5
Hemorrhage/Bleeding	5	5
Spinal Column Injury	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Tinnitus	3	3
Pain	2	2
Spinal Cord Injury	2	2
Nicks, cuts or tears of dura or other tissues by device	1	1
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
Paresis	1	1
Reaction	1	1
Partial thickness (Second Degree) Burn	1	3
Bacterial Infection	1	1
Headache	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap AG	II	Oct-02-2025