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.The device subject of this complaint has not been returned to steris endoscopy for evaluation.Statements from the instructions for use include: "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.When using a guidewire, irrigate the guidewire lumen of the catheter with sterile water/saline." the distributor has offered in-service training to the user facility on behalf of steris endoscopy; however, the user facility has declined.
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