InjuryPID
ESOFLIP
Received Sep 8, 2021 · Event occurred Aug 17, 2021
Report 3006897778-2021-00002 · MDR key 12440915
Device
Generic name
Esophageal Dilator Balloon With Or Without Ele
Manufacturer
Crospon LtdModel number
ES-330Catalog number
ES-330
Lot number
20A1132JZ
Product problems
- Inflation Problem
- Inflation Problem
Patient
Not reported
- Perforation of Esophagus
- Perforation of Esophagus
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, THERE WAS AN ESOPHAGEAL PERFORATION DURING THE PROCEDURE. THE CATHETER LOST PROCEDURE, THEY DEFLATED THEN INFLATED, BUT DID NOT REACH 20 MILLILITER, DEFLATED AGAIN, AND THEY NOTICED THE PERFORATION.