The endo smartcap tubing instructions for use include the instructions for testing the tubing prior to use.The ifu states, "prime the channel and test for air and water prior to insertion of gi endoscope." the customer properly followed these instructions and replaced the tubing set prior to use.The product number (4005644) provided in the report is related to an endogator tubing set and not the endo smartcap tubing as described in the reported event.Steris requested the endo smartcap tubing subject of the reported event back for evaluation.Upon return of the device, the correct product number was confirmed (558597) for the endo smartcap tubing.The endo smartcap tubing subject of the reported event was evaluated and found that the stopcock stem was plugged due to excess glue.The tubing was then functionally tested and the tubing did not provide insufflation.
|