The actual complaint product was not returned for evaluation.A photo of a broken device was provided.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 22-nov-2022 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, inc.Complaint database and identified as complaint: (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.
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It was reported the "tip of the dilator detached and dropped into stomach.The detached part was collected during procedure, no patient injury.Gastrostomy surgery was performed at antrum of stomach inappropriately, so stylet was too close to lesser curvature of stomach.It was supposed that it caused the dilator's damage.The gastrostomy tube replacement was succeeded." there was no reported injury.
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