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