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 or Fails to Launch	244	253
Device Sensing Problem	156	159
Display or Visual Feedback Problem	149	149
Incorrect Interpretation of Signal	129	129
Incorrect, Inadequate or Imprecise Result or Readings	116	119
Application Program Problem	114	117
Human-Device Interface Problem	73	76
Communication or Transmission Problem	68	68
Imprecision	60	65
Incorrect Measurement	50	125
Adverse Event Without Identified Device or Use Problem	47	47
Use of Device Problem	43	43
Connection Problem	42	46
Mechanical Problem	41	42
Material Integrity Problem	39	41
Environmental Compatibility Problem	39	39
Computer Software Problem	27	28
Patient Device Interaction Problem	23	23
Unintended Application Program Shut Down	22	22
No Device Output	17	18
Unexpected Shutdown	14	14
Image Orientation Incorrect	12	12
Audible Prompt/Feedback Problem	11	11
Electrical /Electronic Property Problem	8	8
Insufficient Device Problem Information	7	7
Failure to Read Input Signal	6	6
Electromagnetic Interference	6	6
Power Problem	6	6
Detachment of Device or Device Component	6	6
Overheating of Device	5	5
Output Problem	5	5
Computer Operating System Problem	4	4
Delayed Program or Algorithm Execution	4	4
Failure to Power Up	4	4
Smoking	3	3
Data Problem	3	3
Mechanics Altered	2	2
Component Missing	2	2
Physical Resistance/Sticking	2	2
Fracture	2	2
Break	2	2
Degraded	2	2
Material Fragmentation	2	2
Failure to Shut Off	2	2
Failure to Capture	1	1
Image Display Error/Artifact	1	1
Intermittent Continuity	1	1
Delayed Charge Time	1	1
Gas/Air Leak	1	1
Pumping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1066	1165
Cerebrospinal Fluid Leakage	21	21
Perforation of Vessels	7	7
Insufficient Information	5	8
Stroke/CVA	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
Unspecified Tissue Injury	3	3
Pain	2	2
Unspecified Nervous System Problem	2	2
Cardiac Arrest	2	2
Hypoxia	2	2
Headache	2	2
Incontinence	1	1
Hematoma	1	1
Visual Impairment	1	1
Calcium Deposits/Calcification	1	1
Fatigue	1	1
Electric Shock	1	1
Urinary Retention	1	1
Discomfort	1	1
Post Operative Wound Infection	1	1
Hypoventilation	1	1
Unintended Extubation	1	1
Ambulation or Postural Difficulties	1	1
Burning Sensation	1	1
Obstruction/Occlusion	1	1
Alteration in Body Temperature	1	1
Erythema	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Bacterial Infection	1	1
Low Blood Pressure/ Hypotension	1	1
Loss of Vision	1	1
Urinary Frequency / Polyuria	1	1
Urinary Tract Infection	1	1
Swelling/ Edema	1	1
Anaphylactic Shock	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Acclarent, Inc.	II	Oct-20-2023
2	Acclarent, Inc.	II	Dec-22-2021
3	Integra LifeSciences Corp.	II	Aug-05-2024
4	Integra LifeSciences Corp. (NeuroSciences)	II	Nov-04-2025
5	Stryker Leibinger GmbH & Co. KG	II	May-23-2024