Catalog Number 0747031530 |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/16/2015 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacture 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 during an arthroscopy procedure, the surgeon noticed dried blood in the cavity of the knee which came out of the irrigation cannula.Although low risk of transmission as the cannula has been sterilized in decontamination, the unit bloods have been taken from the affected patient and the previous patient.The patient received hepatitis b vaccination due to the risk of infection.The instrument has been reprocessed.Although there was patient involvement, the procedure was completed successfully.
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Manufacturer Narrative
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"the reported device was not received for investigation; therefore, the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: manufacturing controls: qc incoming and in-process inspections; manufacturing task instructions; instructions for use; design: minimize areas on scope where debris can be trapped or collect.In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation." the product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that during an arthroscopy procedure, the surgeon noticed dried blood in the cavity of the knee which came out of the irrigation cannula.Although low risk of transmission as the cannula has been sterilized in decontamination, the unit bloods have been taken from the affected patient and the previous patient.The patient received hepatitis b vaccination due to the risk of infection.The instrument has been reprocessed.Although there was patient involvement, the procedure was completed successfully.
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Search Alerts/Recalls
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