Model Number UM-G20-29R-3 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, post marketing adverse event reporting for medical products and dietary supplements during a pandemic.The subject device in this report has not been returned to omsc for evaluation because the site discarded the device and all of the parts of the guidewire port.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.It is likely that the guidewire port may have been damaged due to excessive force.
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Event Description
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Olympus medical systems corp.(omsc) was informed by the user that a guidewire port of the subject device broke, and parts of the guidewire port fell off into the patient during intraductal ultrasonography (idc).The user withdrew the parts from the patient and completed the intended procedure by replacing the device with another similar device.There was no patient injury reported.
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Search Alerts/Recalls
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