Date of event: (b)(6) 2018.(b)(6).Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved could not be reviewed because a lot number was not provided.Investigation conclusion: the information provided indicated this device was used to stretch a lapband at gastro esophageal junction.This is against the intended use of the device and the most likely cause for the reported observation.The intended use in the instructions for use state: "this device is used over a pre-positioned savary-gilliard wire guide for dilation of esophageal strictures." the instructions for use also state: "do not use this device for any purpose other than stated intended use." prior to distribution, all savary-gilliard dilator sets are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Additional comments regarding this report: based on the information provided that this device was used to stretch a lapband at the gastroesophageal junction, against its intended use, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
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