STRYKER ENDOSCOPY-SAN JOSE PKG., BARREL BUR, 12 FLUTE F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 0375941012 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Burn, Thermal (2530)
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Event Date 02/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available, it will be provided in future reports.
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Event Description
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It was reported that the patient was burned.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: a plastic joint component was likely broken.The blade did not spin.The failure identified in the investigation is consistent with the complaint record.The probable root cause/s could be an excessive pressure such as bending or prying of the bur and maintained for a substantial amount of time may cause for the drive shaft to finally fail due to material fatigue.A possible cause of the burn could have been excessive loading for an extended period of time with poor or no suction and creating excessive heat, indicated from the bent shaft of the proximal end and the wear marks.
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Event Description
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It was reported that the patient was burned.
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Search Alerts/Recalls
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