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TPLC
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Device
tubing/tubing with filter, insufflation, laparoscopic
Regulation Description
Laparoscopic insufflator.
Product Code
NKC
Regulation Number
884.1730
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
3
3
2021
2
2
2022
2
2
2023
4
4
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Temperature Problem
2
2
Gas/Air Leak
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Leak/Splash
2
2
Output Problem
2
2
Material Separation
1
1
Connection Problem
1
1
Compatibility Problem
1
1
Detachment of Device or Device Component
1
1
Device Handling Problem
1
1
Mechanical Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Failure to Align
1
1
Loss of or Failure to Bond
1
1
Therapeutic or Diagnostic Output Failure
1
1
Break
1
1
Obstruction of Flow
1
1
No Device Output
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7
7
Myocarditis
2
2
Discomfort
2
2
Burn(s)
2
2
Insufficient Information
2
2
No Code Available
1
1
No Known Impact Or Consequence To Patient
1
1
Therapeutic Effects, Unexpected
1
1
Unspecified Respiratory Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Karl Storz Endoscopy
III
May-09-2020
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