TPLC - Total Product Life Cycle

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Device	ear, nose, and throat stereotaxic instrument
Definition	Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
Product Code	PGW
Regulation Number	882.4560
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Freezes, Becomes Nonfunctional	224	224
Human-Device Interface Problem	184	184
Imprecision	136	136
Device Sensing Problem	101	101
Display or Visual Feedback Problem	92	92
Incorrect Interpretation of Signal	91	91
Mechanical Problem	77	77
Material Integrity Problem	67	67
Environmental Compatibility Problem	56	56
Connection Problem	49	49
Adverse Event Without Identified Device or Use Problem	43	43
Application Program Problem	40	40
Communication or Transmission Problem	28	28
Output Problem	25	25
Incorrect, Inadequate or Imprecise Result or Readings	23	23
Computer Software Problem	22	22
Incorrect Measurement	13	13
Patient Device Interaction Problem	12	12
Image Orientation Incorrect	11	11
Image Display Error/Artifact	10	10
Unexpected Shutdown	10	10
Use of Device Problem	9	9
Insufficient Information	7	7
Calibration Problem	5	5
Detachment of Device or Device Component	5	5
Computer Operating System Problem	4	4
Electromagnetic Interference	4	4
Electrical /Electronic Property Problem	4	4
No Device Output	4	4
Unintended Application Program Shut Down	3	3
Audible Prompt/Feedback Problem	3	3
Data Problem	2	2
Smoking	2	2
Material Separation	1	1
Failure to Read Input Signal	1	1
Installation-Related Problem	1	1
Excessive Cooling	1	1
Failure to Shut Off	1	1
Overheating of Device	1	1
Failure to Power Up	1	1
Fire	1	1
Fracture	1	1
Material Fragmentation	1	1
Break	1	1
Insufficient Cooling	1	1
Degraded	1	1
Delayed Program or Algorithm Execution	1	1
Excessive Heating	1	1
Power Problem	1	1
Mechanics Altered	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	670	670
No Known Impact Or Consequence To Patient	280	280
No Patient Involvement	91	91
No Consequences Or Impact To Patient	16	16
Cerebrospinal Fluid Leakage	9	9
Perforation of Vessels	7	7
Stroke/CVA	4	4
Hemorrhage/Bleeding	4	4
Unspecified Tissue Injury	3	3
Unspecified Nervous System Problem	2	2
Tissue Damage	2	2
Headache	2	2
Complaint, Ill-Defined	2	2
Iatrogenic Source	1	1
Visual Impairment	1	1
Loss of Vision	1	1
Hematoma	1	1
Inflammation	1	1
Pain	1	1
Swelling	1	1
Erythema	1	1
Adhesion(s)	1	1
Burn(s)	1	1