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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bougie, esophageal, and gastrointestinal, gastro-urology
Product CodeFAT
Regulation Number 876.5365
Device Class 2


Premarket Reviews
ManufacturerDecision
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 3 3
2019 1 1
2020 2 2
2021 2 2
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 2 2
Detachment of Device or Device Component 2 2
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Burst Container or Vessel 1 1
Device Expiration Issue 1 1
Leak/Splash 1 1
Delivered as Unsterile Product 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3 3
No Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Nausea 1 1
Pain 1 1
Perforation 1 1
Vomiting 1 1
No Consequences Or Impact To Patient 1 1
Chemical Exposure 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Endoscopy II Feb-01-2011
2 Stryker Endoscopy II Dec-28-2010
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