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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 7
BIOSENSE WEBSTER
  SUBSTANTIALLY EQUIVALENT 2
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 10
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 4
SCOPIS GMBH
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORPORATE
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENT
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 7 7
2015 14 14
2016 33 33
2017 42 42
2018 96 96
2019 247 247
2020 161 161
2021 190 190
2022 167 167
2023 210 210
2024 92 92

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 225 225
Human-Device Interface Problem 200 200
Imprecision 184 184
Device Sensing Problem 105 105
Display or Visual Feedback Problem 96 96
Incorrect Interpretation of Signal 91 91
Mechanical Problem 85 85
Communication or Transmission Problem 72 72
Material Integrity Problem 69 69
Environmental Compatibility Problem 57 57
Connection Problem 49 49
Adverse Event Without Identified Device or Use Problem 46 46
Device Operates Differently Than Expected 44 44
Application Program Problem 41 41
Computer Software Problem 30 30
Output Problem 29 29
Incorrect, Inadequate or Imprecise Result or Readings 23 23
Device Stops Intermittently 23 23
Application Interface Becomes Non-Functional Or Program Exits Abnormally 16 16
Image Orientation Incorrect 14 14
Incorrect Measurement 13 13
Patient Device Interaction Problem 12 12
Image Display Error/Artifact 11 11
Unexpected Shutdown 10 10
Use of Device Problem 9 9
Device Displays Incorrect Message 8 8
Insufficient Information 7 7
Electrical /Electronic Property Problem 7 7
Suction Problem 5 5
Calibration Problem 5 5
Device Inoperable 5 5
Detachment of Device or Device Component 5 5
Computer Operating System Problem 4 4
Material Deformation 4 4
No Device Output 4 4
Electromagnetic Interference 4 4
No Display/Image 3 3
Data Problem 3 3
Unintended Application Program Shut Down 3 3
Audible Prompt/Feedback Problem 3 3
Intermittent Communication Failure 2 2
Erratic or Intermittent Display 2 2
Bent 2 2
Fracture 2 2
Smoking 2 2
Device Issue 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Material Separation 1 1
Failure to Read Input Signal 1 1
Material Fragmentation 1 1
Fire 1 1
Break 1 1
Insufficient Cooling 1 1
Degraded 1 1
Excessive Heating 1 1
Delayed Program or Algorithm Execution 1 1
Excessive Cooling 1 1
Failure to Shut Off 1 1
Installation-Related Problem 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 344 344
No Patient Involvement 147 147
No Consequences Or Impact To Patient 85 85
Cerebrospinal Fluid Leakage 10 10
Perforation of Vessels 7 7
Therapeutic Effects, Unexpected 4 4
Hemorrhage/Bleeding 4 4
Stroke/CVA 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 2 2
Visual Impairment 1 1
Loss of Vision 1 1
Hematoma 1 1
Inflammation 1 1
Pain 1 1
Paresis 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 Oct-20-2023
2 Acclarent, Inc. II Dec-22-2021
3 Acclarent, Inc. II Jan-19-2020
4 Medtronic Navigation, Inc. II Aug-21-2017
5 Stryker Instruments Div. of Stryker Corporation II Apr-19-2017
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