Model Number UM-S20-17S |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned by the customer, without the protocol observed for biohazard material, in a condition whereby the evaluation of the device could not be performed.The customer will be resending the device with the biohazard protocol observed.As such, the device is not evaluated as yet, and a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
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Event Description
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As reported for this event by the customer, during reprocessing immediately after a procedure, it was observed that there was presence of blood inside the ultrasound tip.There is no possibility that the device was used in any other procedure with the presence of blood inside the ultrasound tip.There is no harm to any patient or persons.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The subject device was returned and an evaluation completed for it where the users complaint was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that there is a perforation in the sheath where blood or body fluid may have entered the sheath.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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