Pediatric Esophageal Atresia Anastomosis Device
Gastroenterology, Urology · 21 CFR 876.5980
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.
Recent MDR events
43 adverse event reports on file
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIAMay 30, 2023MalfunctionWilson-cook Medical Inc1037905-2023-00258
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIAMay 9, 2023MalfunctionWilson-cook Medical Inc1037905-2023-00211
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIAApr 26, 2023InjuryWilson-cook Medical Inc1037905-2023-00188
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIAMar 3, 2023InjuryWilson-cook Medical Inc1037905-2023-00103
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIAMar 3, 2023InjuryWilson-cook Medical Inc1037905-2023-00106
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIAFeb 1, 2023InjuryWilson-cook Medical Inc1037905-2023-00039
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIAJan 13, 2023InjuryWilson-cook Medical Inc1037905-2023-00022
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIANov 10, 2022InjuryWilson-cook Medical Inc1037905-2022-00621
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIANov 10, 2022InjuryWilson-cook Medical Inc1037905-2022-00623
- FLOURISH PEDIATRIC ESOPHAGEAL ATRESIAOct 21, 2022InjuryWilson-cook Medical Inc1037905-2022-00582
Event type breakdown
Most-reported manufacturers
Recalls
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Registered firms
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510(k) clearances
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