Through follow-up with the user facility, us endoscopy has learned that lubricant was not applied to the device housing.Lubrication of this device prior to insertion is required and specified in the instructions for use.The device subject of the reported event was discarded by the user facility and is not available for evaluation.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "carefully apply lubricant liberally to the outside of the padlock clip housing.Pass endoscope loaded with padlock clip delivery system cautiously through cricopharyngeal area of patient." us endoscopy has provided in-service training to the user facility, including instruction on proper lubrication of the device housing.No additional issues have been reported.
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