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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device light, catheter, fiberoptic, glass, ureteral
Product CodeFCS
Regulation Number 876.4020
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 5 5
2016 3 3
2017 17 17
2018 6 6
2019 4 4
2020 8 8
2021 6 6
2022 19 19
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Packaging Problem 10 10
Overheating of Device 8 8
Melted 7 7
Device Operates Differently Than Expected 7 7
Device Contamination with Chemical or Other Material 6 6
Contamination /Decontamination Problem 5 5
Output Problem 5 5
Device Unsafe to Use in Environment 4 4
Insufficient Information 4 4
Contamination 4 4
Use of Device Problem 4 4
Smoking 3 3
Patient-Device Incompatibility 3 3
No Device Output 2 2
Therapeutic or Diagnostic Output Failure 2 2
Optical Problem 2 2
Structural Problem 2 2
Expiration Date Error 2 2
Break 2 2
Fracture 2 2
Difficult to Insert 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Bent 1 1
Electrical /Electronic Property Problem 1 1
Defective Device 1 1
Device Contamination with Body Fluid 1 1
Device Stops Intermittently 1 1
Device Inoperable 1 1
Failure to Power Up 1 1
Material Separation 1 1
Difficult to Advance 1 1
Appropriate Term/Code Not Available 1 1
Activation Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Markings/Labelling Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 26 26
Insufficient Information 22 22
No Consequences Or Impact To Patient 4 4
Burn(s) 3 3
Renal Failure 3 3
Swelling 2 2
Hemorrhage/Bleeding 2 2
Pain 2 2
Genital Bleeding 2 2
Perforation 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Uterine Perforation 1 1
Injury 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Inc. II Apr-19-2017
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