Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device pediatric esophageal atresia anastomosis device
Definition Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter.
Product CodePTK
Regulation Number 876.5980
Device Class 3

MDR Year MDR Reports MDR Events
2018 1 1
2019 5 5
2020 9 9
2021 13 13
2022 8 8
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Advance 16 16
Patient-Device Incompatibility 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Off-Label Use 2 2
Improper or Incorrect Procedure or Method 2 2
Patient Device Interaction Problem 1 1
Failure to Align 1 1
Appropriate Term/Code Not Available 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure to Anastomose 16 16
No Clinical Signs, Symptoms or Conditions 11 11
Stenosis of the esophagus 10 10
Perforation of Esophagus 4 4
Fistula 4 4
No Consequences Or Impact To Patient 3 3
Stenosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Wheezing 1 1
Laceration(s) of Esophagus 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Pneumonia 1 1
Hyperventilation 1 1
Erosion 1 1
Respiratory Insufficiency 1 1
Bronchitis 1 1

-
-