Pentax medical became aware of a report on 03-feb-2020 stating, "the axios stent did not come out in the axis because the erector did not open at 0 degrees - this caused friction on the wall of the esophagus, created a lesion with bleeding and obliged the physician to put clips to stop the bleeding." involving digital linear ultrasound scope model eg38-j10ut/serial (b)(4).The customer reported using boston scientific axios system,, which is not listed as recommended for use within the instructions for use(ifu) of the eg38-j10ut compatibility section.The user facility used the endoscope on the patient without checking before use that the endoscope elevator could be "opened".Lastly, the user facility removed the endoscope from the patient without realizing that the tip of axios was sticking out of the elevator.As a result, the patient's esophageal wall was damaged by the tip of boston scientific axios product.The endoscope was not returned to pentax medical for evaluation and the user facility continues to use the endoscope.
|