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Model Number SB4000SA |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/24/2020 |
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 the device approximately 10 to 15 minutes during the endoscopic sinus surgery (ess) procedure, the blade axis broke in the nasal cavity.According to the reporter, the subject device was replaced with the same similar device and the intended procedure was completed with no harm or impact to the patient.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Physical inspection of device could be performed as the device was discarded at the medical facility.As the device was not returned to the oem (original equipment manufacturer) for physical inspection, a root cause cannot be determined for the reported failure.Olympus will continue to monitor complaints for this device.
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Search Alerts/Recalls
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