The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30099759 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).Device not returned.
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It was reported via the distributor that during the procedure, once the peel away sheath was left and after the dilator was removed, the doctor discovered that a piece of the dilator was inside the patient, on the stomach.The piece was removed via endoscope.The patient was described only as "an adult." no further information has been provided at this time.
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