The disposable infinity cytology brush is intended to be used to retrieve cytological cell samples in the gastrointestinal tract.A portion of the device was returned to us endoscopy.The brush head was not returned.Examination of the return confirmed the report of a detached brush head, however the report could not be fully investigated without the brush head component.The device history records for this lot was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with devices from this lot.The device's instructions for use state: "the brush should never be forced through the endoscope's channel.If resistance is met due to excess angulation of the endoscope, it may be necessary to decrease the angulation to allow passage of the brush.Prior to clinical use, familiarize yourself with the device and read all the instructions for use.Inspect the package for shipping or handling damage.If damage is evident, do not use this device and contact your product specialist.Fully retract and deploy the spool handle and thumb ring 3-4 times to ensure the device functions properly and is not damaged.If damage is evident, do not use this device." us endoscopy offered in-service training, however the user facility has declined.
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