STRYKER ENDOSCOPY-SAN JOSE PKG., ROUND BUR, 12 FLUTE F-SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 0375940012 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 10/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that the device broke during procedure.All pieces were removed successfully.
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Manufacturer Narrative
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Alleged failure: break.Probable root cause: - inadequate window profile - inadequate welding process (i.E.Plasma, inductive, gluing) - improper material strength - inadequate size selected for the application - material brittleness - excessive force applied by the user - incorrect rfid tag.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that the device broke during procedure.All pieces were removed successfully.
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Search Alerts/Recalls
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