Model Number URF-V3 |
Device Problems
Residue After Decontamination (2325); Failure to Clean Adequately (4048)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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Event Description
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As reported, a foreign substance coming out from inside the scope when used was observed.The issue found during an unspecified procedure.There is no patient harm or injury reported on this reported event.There is no patient infection associated on this reported event.No user injury reported.
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Manufacturer Narrative
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This report is being supplemented to provide additional information obtained from the customer and the approved final investigation.Based on the results of the device evaluation and investigation, the biopsy channel was torn and leaked, the adhesive on the bending section was chipped, and the unit failed the water dunk test.Although the definitive root cause of the reported issue could not be determined, a probable cause of the torn biopsy channel was improper laser radiation or contact by a therapeutic accessory, which may have cause a piece of carbon to be ejected from the inside of the insertion section.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: "if laser radiation is activated when the distal end of the laser prove is not visible within an endoscopic image, the device may be damaged.Do not forcibly insert endotherapy accessories.If an endoscope having leakage is used, a malfunction may occur." olympus will continue to monitor field performance for this device.
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Event Description
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The procedure was an unknown, diagnostic one.The procedure was completed with a short delay.The device was inspected before use, and nothing was found to be wrong with the device.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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