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U.S. Department of Health and Human Services

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 CodePGW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC
  SUBSTANTIALLY EQUIVALENT 1
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 5
BIOSENSE WEBSTER
  SUBSTANTIALLY EQUIVALENT 1
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC NAVIGATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCOPIS GMBH
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENT
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 42 42
2018 96 96
2019 247 247
2020 161 161
2021 190 190
2022 150 150

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 173 173
Application Program Freezes, Becomes Nonfunctional 166 166
Imprecision 162 162
Mechanical Problem 77 77
Communication or Transmission Problem 65 65
Device Sensing Problem 58 58
Material Integrity Problem 56 56
Display or Visual Feedback Problem 54 54
Environmental Compatibility Problem 47 47
Connection Problem 39 39
Device Operates Differently Than Expected 30 30
Output Problem 28 28
Adverse Event Without Identified Device or Use Problem 26 26
Computer Software Problem 26 26
Incorrect Interpretation of Signal 15 15
Image Display Error/Artifact 11 11
Device Stops Intermittently 10 10
Application Interface Becomes Non-Functional Or Program Exits Abnormally 8 8
Device Displays Incorrect Message 6 6
Calibration Problem 5 5
Detachment of Device or Device Component 5 5
Computer Operating System Problem 4 4
Electrical /Electronic Property Problem 4 4
Image Orientation Incorrect 4 4
Incorrect Measurement 4 4
Electromagnetic Interference 3 3
Application Program Problem 3 3
Device Inoperable 3 3
Data Problem 3 3
Audible Prompt/Feedback Problem 3 3
Intermittent Communication Failure 2 2
Erratic or Intermittent Display 2 2
No Display/Image 2 2
Fracture 2 2
Material Fragmentation 1 1
Failure to Power Up 1 1
Insufficient Cooling 1 1
Fire 1 1
Device Issue 1 1
Material Separation 1 1
Break 1 1
Excessive Cooling 1 1
Failure to Shut Off 1 1
Excessive Heating 1 1
Insufficient Information 1 1
Mechanics Altered 1 1
Installation-Related Problem 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 368 368
No Known Impact Or Consequence To Patient 334 334
No Patient Involvement 146 146
No Consequences Or Impact To Patient 44 44
Therapeutic Effects, Unexpected 4 4
Cerebrospinal Fluid Leakage 4 4
Headache 2 2
Tissue Damage 2 2
Complaint, Ill-Defined 2 2
Iatrogenic Source 1 1
Unspecified Tissue Injury 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

Recalls
Manufacturer Recall Class Date Posted
1 Acclarent, Inc. II Dec-22-2021
2 Acclarent, Inc. II Jan-19-2020
3 Medtronic Navigation, Inc. II Aug-21-2017
4 Stryker Instruments Div. of Stryker Corporation II Apr-19-2017
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