Through follow up with the user facility, steris endoscopy has learned that the lack of insufflation was detected during set-up prior to the procedure, and that the procedure was completed with a fourth 00711556 irrigation kit.The lot number 2009099 stated in the initial report is not a valid lot number for this device.Upon follow up with the user facility, steris endoscopy has determined that the correct lot number of the device subject of this report is 2008099.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Statements from the instructions for use include: "prior to clinical use, inspect and familiarize yourself with the device and review the diagram below.If there is evidence of damage, do not use this product and contact your local product specialist.Remove 1/3 of the sterile water from the full sterile water bottle.This will allow for improved water pressure for better insufflation and water flow.Insert the water bottle tubing into the sterile water bottle and firmly tighten the threaded lid cap to ensure a seal." the device subject of this complaint has not been received for evaluation.Steris endoscopy offered in-service training to the user facility on the proper use and setup of the irrigation kit; user facility response is pending.No further issues have been reported.
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