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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 2 2

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
Device Operates Differently Than Expected 7 7
Melted 7 7
Device Contamination with Chemical or Other Material 6 6
Output Problem 6 6
Contamination /Decontamination Problem 5 5
Contamination 4 4
Use of Device Problem 4 4
Device Unsafe to Use in Environment 4 4
Insufficient Information 4 4
Smoking 3 3
Patient-Device Incompatibility 3 3
Therapeutic or Diagnostic Output Failure 2 2
Expiration Date Error 2 2
Structural Problem 2 2
Optical Problem 2 2
Fracture 2 2
No Device Output 2 2
Break 2 2
Device Contaminated During Manufacture or Shipping 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Difficult to Insert 1 1
Material Separation 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Inoperable 1 1
Device Stops Intermittently 1 1
Failure to Power Up 1 1
Bent 1 1
Delivered as Unsterile Product 1 1
Appropriate Term/Code Not Available 1 1
Device Contamination with Body Fluid 1 1
Activation Problem 1 1
Device Markings/Labelling Problem 1 1
Difficult to Advance 1 1
Nonstandard Device 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
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
Genital Bleeding 2 2
Swelling 2 2
Pain 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Uterine Perforation 1 1
Perforation 1 1
Blood Loss 1 1
Injury 1 1
Urinary Retention 1 1
No Patient Involvement 1 1
Tissue Damage 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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