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Model Number BUR3070DB |
Device Problem
Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
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Event Description
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It was reported that during a functional endoscopic sinus surgery (fess) procedure, the device did not performed as intended.According to the reporter, 3 pieces of burrs were opened and none of them worked.The user changed the handpieces and consoles however, the issue was not resolved.A straight burr was opened and the intended procedure was completed.The or (operating room ) time was increased to approximately 2 hours and 17 minutes due to the event.There were no further details provided due to the event.No patient harm, or injury reported.No user injury reported.This is related to patient identifiers (b)(6).
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Manufacturer Narrative
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This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr) and investigation conclusion.The device was returned and there was no sign of damage with the device.The customer phenomenon of the burr not working as intended was not confirmed.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause could not be determined as the customer phenomenon could not be identified.Due to device having passed all functional tests and having no visual abnormalities and evidence of device being inspected by manufacturing prior to being shipped to the customer by dhr evaluation, it is unlikely the unit left the facility damaged.Therefore, the malfunction incurred, may have been as result of use.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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