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
Contamination (1120)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2021 |
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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Alleged failure: between the blade was a strange object when customer opened the package.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be the improper cleaning process, qc incoming, and in-process inspections.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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