STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, F- SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 0375544000 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.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 there was foreign material in the sterile packaging.
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Manufacturer Narrative
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Manufacture date is not known.Alleged failure: a blue foreign material was found inside the package.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be improper cleaning process, qc incoming, and in-process inspections, environmental conditions.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that there was foreign material in the sterile packaging.
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Search Alerts/Recalls
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