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Model Number URF-P7R |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2022 |
Event Type
malfunction
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Event Description
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A user facility reported to olympus that a leak was present in the device, identified during reprocessing of the device.Upon inspection of the device, performed by a field service engineer (fse), the fse noted that metal was sticking out of the bending rubber, multiple black dots were present in the image and a leak in the bending section was observed.This report is submitted due to the report of metal sticking out of the bending rubber.There was no patient injury, associated with the problems, reported to olympus.
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Manufacturer Narrative
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The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation determined that the bending rubber had been cut, but there was no metal sticking out.The angulation problem was not found.The evaluation found leakage from the bending section, multiple black dots on the image, the eyepiece was deformed, the bending tube was damaged, the image guide bundle had significant breakages, and the control unit had corrosion due to water leakage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Search Alerts/Recalls
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