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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
  1.  K202609  Instrument Clamps Electromagnetic
  2.  K221098  Scopis ENT Software, Scopis ENT Software with TGS, ...
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 96 96

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 162 162
Application Program Freezes, Becomes Nonfunctional 152 152
Imprecision 147 147
Mechanical Problem 77 77
Communication or Transmission Problem 64 64
Display or Visual Feedback Problem 54 54
Material Integrity Problem 52 52
Device Sensing Problem 45 45
Environmental Compatibility Problem 44 44
Connection Problem 38 38
Device Operates Differently Than Expected 30 30
Output Problem 28 28
Computer Software Problem 26 26
Adverse Event Without Identified Device or Use Problem 25 25
Image Display Error/Artifact 11 11
Incorrect Interpretation of Signal 10 10
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 3 3
Incorrect Measurement 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
Fracture 2 2
Erratic or Intermittent Display 2 2
No Display/Image 2 2
Insufficient Cooling 1 1
Material Fragmentation 1 1
Material Separation 1 1
Failure to Power Up 1 1
Device Issue 1 1
Break 1 1
Installation-Related Problem 1 1
Material Deformation 1 1
Excessive Cooling 1 1
Failure to Shut Off 1 1
Excessive Heating 1 1
Insufficient Information 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 334 334
No Clinical Signs, Symptoms or Conditions 315 315
No Patient Involvement 146 146
No Consequences Or Impact To Patient 44 44
Therapeutic Effects, Unexpected 4 4
Cerebrospinal Fluid Leakage 3 3
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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