STRYKER ENDOSCOPY-SAN JOSE PKG., BARREL BUR, 6 FLUTE F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 0375941000 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/14/2019 |
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 there was foreign material inside the sterile packaging.
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Event Description
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It was reported that there was foreign material inside the sterile packaging.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: foreign material inside sterile packaging.Probable root cause: foreign material left in the device stains corrosion inadequate cleaning process environmental conditions dents scratches shipping damage the reported failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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