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TPLC
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show TPLC since
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Device
light, catheter, fiberoptic, glass, ureteral
Product Code
FCS
Regulation Number
876.4020
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
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
Structural Problem
2
2
Optical Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Expiration Date Error
2
2
Fracture
2
2
Break
2
2
No Device Output
2
2
Difficult to Advance
1
1
Difficult to Insert
1
1
Delivered as Unsterile Product
1
1
Bent
1
1
Electrical /Electronic Property Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Device Markings/Labelling Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Defective Device
1
1
Material Integrity Problem
1
1
Appropriate Term/Code Not Available
1
1
Nonstandard Device
1
1
Device Inoperable
1
1
Device Stops Intermittently
1
1
Activation Problem
1
1
Device Contamination with Body Fluid
1
1
Failure to Power Up
1
1
Material Separation
1
1
Contamination of Device Ingredient or Reagent
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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