TPLC - Total Product Life Cycle

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Device	ear, nose, and throat stereotaxic instrument
Regulation Description	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	247	247
Device Sensing Problem	151	151
Display or Visual Feedback Problem	125	125
Incorrect Interpretation of Signal	121	121
Human-Device Interface Problem	103	103
Application Program Problem	95	95
Imprecision	88	88
Incorrect, Inadequate or Imprecise Result or Readings	61	61
Communication or Transmission Problem	55	55
Mechanical Problem	54	54
Material Integrity Problem	53	53
Connection Problem	50	50
Environmental Compatibility Problem	49	49
Adverse Event Without Identified Device or Use Problem	44	44
Use of Device Problem	29	29
Computer Software Problem	23	23
Patient Device Interaction Problem	23	23
Incorrect Measurement	21	57
Unintended Application Program Shut Down	18	18
Unexpected Shutdown	13	13
No Device Output	12	12
Image Orientation Incorrect	12	12
Electrical /Electronic Property Problem	7	7
Insufficient Information	7	7
Detachment of Device or Device Component	6	6
Output Problem	5	5
Computer Operating System Problem	4	4
Audible Prompt/Feedback Problem	4	4
Electromagnetic Interference	4	4
Failure to Read Input Signal	3	3
Data Problem	3	3
Power Problem	3	3
Mechanics Altered	2	2
Failure to Shut Off	2	2
Fracture	2	2
Component Missing	2	2
Break	2	2
Failure to Power Up	2	2
Material Fragmentation	2	2
Degraded	2	2
Smoking	2	2
Overheating of Device	2	2
Delayed Program or Algorithm Execution	2	2
Improper or Incorrect Procedure or Method	1	1
Delayed Charge Time	1	1
Device Displays Incorrect Message	1	1
Capturing Problem	1	1
Excessive Heating	1	1
Appropriate Term/Code Not Available	1	1
Loss of Data	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	914	950
No Known Impact Or Consequence To Patient	108	108
No Patient Involvement	34	34
Cerebrospinal Fluid Leakage	19	19
Perforation of Vessels	7	7
Stroke/CVA	4	4
Hemorrhage/Bleeding	4	4
Unspecified Tissue Injury	3	3
Unspecified Nervous System Problem	2	2
Insufficient Information	2	2
Pain	2	2
Hypoxia	2	2
Headache	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypoventilation	1	1
Electric Shock	1	1
Fatigue	1	1
Hematoma	1	1
Obstruction/Occlusion	1	1
Cardiac Arrest	1	1
Incontinence	1	1
Post Operative Wound Infection	1	1
Burn(s)	1	1
Burning Sensation	1	1
Erythema	1	1
Urinary Retention	1	1
Discomfort	1	1
Alteration in Body Temperature	1	1
Visual Impairment	1	1
Anaphylactic Shock	1	1
Calcium Deposits/Calcification	1	1
Swelling/ Edema	1	1
Bacterial Infection	1	1
Loss of Vision	1	1
No Consequences Or Impact To Patient	1	1
Urinary Frequency	1	1
Low Blood Pressure/ Hypotension	1	1
Unintended Extubation	1	1
Urinary Tract Infection	1	1
Ambulation Difficulties	1	1