It was reported that in the middle of a therapeutic esophageal dilation procedure two balloon devices burst.There was a delay approximately 3 to 5 minutes while the patient was under n-acetylcysteine (nac) anesthesia.The procedure was completed with balloon and syringe from a different lot (lot number unknown).No pieces of the balloon fell into the patient.The devices were inspected prior to use with no abnormalities found.The balloons were not lubricated.The balloons were not tied in a knot nor was string used to tie off the balloon end.The dilator was not used with a test balloon.There were no resistance noted during insertion, or withdrawal of the balloon.There was no patient harm, or injury reported due to the event.No user injury reported.This report is related to report patient identifier: (b)(6).
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This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g4, g7, h2, h6, and h10.Physical evaluation cannot be completed as the subject device was not returned and the customer did not provide any pictures of the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus will continue to monitor complaints for this device.
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