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TPLC
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Device
esophageal dilator balloon with or without electrode sensors
Definition
To dilate the lower esophageal sphincter of patients with Achalasia.
Product Code
PID
Regulation Number
876.5980
Device Class
2
Premarket Reviews
Manufacturer
Decision
WILSON-COOK MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2
2
2020
4
4
2021
10
10
2022
9
9
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Burst Container or Vessel
12
12
Adverse Event Without Identified Device or Use Problem
7
7
Inflation Problem
2
2
Product Quality Problem
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Difficult to Advance
1
1
Material Twisted/Bent
1
1
Appropriate Term/Code Not Available
1
1
Crack
1
1
Deflation Problem
1
1
Break
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14
14
No Consequences Or Impact To Patient
5
5
Perforation of Esophagus
5
5
Perforation
3
3
Unintended Radiation Exposure
2
2
Hemorrhage/Bleeding
1
1
No Code Available
1
1
Syncope/Fainting
1
1
Asystole
1
1
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