The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 30106554 was reviewed and the product was produced according to product specifications.All information reasonably known as of 05 aug 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
|
It was reported to the sales representative that one of the saf-t-pexy sutures in the kit deployed prematurely.The first one used deployed perfectly, however, the second suture's blue 'locking' mechanism was not moved and the inner cylinder was not yet pushed into the outer cylinder, and yet the saf-t-pexy suture deployed into the patient's peritoneum lining.The doctor was unable to remove it.There was no injury to the patient.The procedure was not completed after the reported incident, as the surgeon felt the patient's anatomy was not suited for a feeding tube.
|