STRYKER ENDOSCOPY-SAN JOSE PKG., TOMCAT SHAVER BLADE, F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 0375545000 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
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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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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: opened the box and it looked like there was a skin or tissue hanging.The failure(s) identified in the investigation is consistent with the complaint record.Per visual inspection of the unit, the white material present in the window was the white grease.The grease was a part of the assembly, it was applied to the inner cutter shaft during assembly and the possibility of the white grease will migrate to the cutting window if the inner cutter was removed from the housing and push back in the housing.The probable root cause/s could be the inner blade was removed or slightly moved from the housing and push back inside the housing.Improper cleaning process, qc incoming and in-process inspections.The reported failure mode will be monitored for future reoccurrence.Gtin: (b)(4).
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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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Search Alerts/Recalls
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