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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device septal stapler/absorbable staples
Definition To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.
Product CodeOLL
Regulation Number 878.4750
Device Class 2


Premarket Reviews
ManufacturerDecision
ENTRIGUE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 7 7
2016 1 1
2017 2 2
2018 6 6
2019 2 2
2020 1 1
2022 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 5 5
Failure to Fire 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Failure to Form Staple 2 2
Material Separation 2 2
Detachment of Device or Device Component 2 2
Break 2 2
Insufficient Information 1 1
Positioning Failure 1 1
Component Falling 1 1
Detachment Of Device Component 1 1
Mechanical Jam 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 9 9
No Information 2 2
Perforation 2 2
Laceration(s) 2 2
No Consequences Or Impact To Patient 2 2
Impaired Healing 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Adhesion(s) 1 1
Inflammation 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Insufficient Information 1 1
Eye Injury 1 1
Nasal Obstruction 1 1
Tissue Damage 1 1

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