A portion of the device subject of this event was returned to steris endoscopy for evaluation.However, the distal end of the returned device had been removed and therefore an examination of the reported detachment could not be completed.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: "do not force the brush through the endoscope's channel.Reduce angulation of the scope if resistance is met.Prior to procedure, actuate the handle several times to be sure the brush functions properly.If the unit does not function properly, or there is evidence of damage (e.G., bent brush, bent brush stem, kinked catheter), do not use this product and contact your local product specialist." steris endoscopy provided in-service training to the user facility on use of the infinity sampling device on (b)(6) 2020.No further issues have been reported.
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The user facility reported that while sampling a stricture in the biliary tract the brush of an infinity sampling device became detached.The brush component was removed from the biliary tract with a forceps, then retrieved with a snare and hood.The procedure was completed successfully, and the tissue sample was obtained.
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