GYRUS ACMI, INC BURR 3 MM, DIAMOND FINE, 10-25MM VAR EXPOSURE, USE WITH MDSSA AND MDASA; FORCEPS
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Model Number MBUR3060DVF |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The reported issue was found prior to use.The device has not yet been returned for evaluation.The investigation is ongoing.If additional information becomes available following device evaluation and investigation, a supplemental report will be filed.
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Event Description
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It was reported that an alternate burr was found inside the package, other than what was listed on the package label.It is labelled diego elite high speed drill burrs packet and shows 3060dvf burr, but contains 3060frcv cutting burr.
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Manufacturer Narrative
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This report is being updated in the following fields: a1, d4, g4, g7, h2, h6 and h10.A review of the device history record was completed and no abnormalities in documentation or process were found.Udi# (b)(4).
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Search Alerts/Recalls
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