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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
Output Problem 6 6
Device Contamination with Chemical or Other Material 6 6
Contamination /Decontamination Problem 5 5
Insufficient Information 4 4
Contamination 4 4
Use of Device Problem 4 4
Device Unsafe to Use in Environment 4 4
Patient-Device Incompatibility 3 3
Smoking 3 3
Break 2 2
Expiration Date Error 2 2
Therapeutic or Diagnostic Output Failure 2 2
Structural Problem 2 2
Optical Problem 2 2
Fracture 2 2
No Device Output 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
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Difficult to Insert 1 1
Failure to Power Up 1 1
Bent 1 1
Delivered as Unsterile Product 1 1
Material Separation 1 1
Contamination of Device Ingredient or Reagent 1 1
Appropriate Term/Code Not Available 1 1
Nonstandard Device 1 1
Device Stops Intermittently 1 1
Device Inoperable 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
Uterine Perforation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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