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 Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that foreign material was found inside in sterile packaging.No delay and no adverse consequences were reported.
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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: when opening the pouch, the nurse observed the presence of a little green plastic in the bur shaft.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be an operator accidentally scraped the sharp part of the cutter with the gloves during assembly and remained attached to the unit, improper cleaning process, qc incoming and in-process inspections.Gtin: (b)(4).
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Event Description
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It was reported that foregin material was found inside in sterile packaging.No delay and no adverse consequences were reported.
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Search Alerts/Recalls
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