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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 176 189

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 235 235
Human-Device Interface Problem 201 201
Imprecision 184 184
Device Sensing Problem 117 117
Display or Visual Feedback Problem 110 110
Incorrect Interpretation of Signal 107 107
Mechanical Problem 92 92
Communication or Transmission Problem 77 77
Material Integrity Problem 70 70
Application Program Problem 60 60
Environmental Compatibility Problem 58 58
Connection Problem 50 50
Adverse Event Without Identified Device or Use Problem 49 49
Device Operates Differently Than Expected 44 44
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Computer Software Problem 32 32
Output Problem 30 30
Device Stops Intermittently 23 23
Use of Device Problem 18 18
Incorrect Measurement 17 30
Patient Device Interaction Problem 17 17
Application Interface Becomes Non-Functional Or Program Exits Abnormally 16 16
Image Orientation Incorrect 15 15
Image Display Error/Artifact 12 12
Unexpected Shutdown 12 12
Unintended Application Program Shut Down 11 11
Device Displays Incorrect Message 9 9
Insufficient Information 8 8
Electrical /Electronic Property Problem 8 8
No Device Output 7 7
Detachment of Device or Device Component 6 6
Audible Prompt/Feedback Problem 5 5
Device Inoperable 5 5
Suction Problem 5 5
Calibration Problem 5 5
Material Deformation 5 5
No Display/Image 4 4
Electromagnetic Interference 4 4
Data Problem 4 4
Computer Operating System Problem 4 4
Erratic or Intermittent Display 3 3
Fracture 3 3
Power Problem 2 2
Mechanics Altered 2 2
Break 2 2
Overheating of Device 2 2
Smoking 2 2
Intermittent Communication Failure 2 2
Bent 2 2
Degraded 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 747 760
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 16 16
Perforation of Vessels 7 7
Stroke/CVA 4 4
Therapeutic Effects, Unexpected 4 4
Hemorrhage/Bleeding 4 4
Unspecified Tissue Injury 3 3
Complaint, Ill-Defined 2 2
Hematoma 2 2
Iatrogenic Source 2 2
Unspecified Nervous System Problem 2 2
Headache 2 2
Tissue Damage 2 2
Insufficient Information 2 2
Pain 2 2
Ambulation Difficulties 1 1
Urinary Tract Infection 1 1
Unintended Extubation 1 1
Low Blood Pressure/ Hypotension 1 1
Urinary Frequency 1 1
Loss of Vision 1 1
Bacterial Infection 1 1
Swelling/ Edema 1 1
Calcium Deposits/Calcification 1 1
Anaphylactic Shock 1 1
Visual Impairment 1 1
Paresis 1 1
Alteration in Body Temperature 1 1
Discomfort 1 1
Urinary Retention 1 1
Swelling 1 1
Erythema 1 1
Burning Sensation 1 1
Burn(s) 1 1
Post Operative Wound Infection 1 1
Incontinence 1 1
Cardiac Arrest 1 1
Obstruction/Occlusion 1 1
Inflammation 1 1
Adhesion(s) 1 1
Fatigue 1 1
Electric Shock 1 1
Hypoventilation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Integra LifeSciences Corp. II Aug-05-2024
5 Medtronic Navigation, Inc. II Aug-21-2017
6 Stryker Instruments Div. of Stryker Corporation II Apr-19-2017
7 Stryker Leibinger GmbH & Co. KG II May-23-2024
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