STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C
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Catalog Number 0502904030 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 05/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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.
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Event Description
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It was reported the device contributed to patient infection.
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Manufacturer Narrative
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Scope was sent in as a repair with only please evaluate no complaint attached.Scope was decontaminated, evaluated and sent out prior to notification that a bacterial testing should done as there have been 3 patient infections tied back to this specific serial number at the acct, thus the reported failure was not confirmed.Alleged failure: 3 patient infections tied back to this specific serial number at the acct.Confirmed failure: outer tube damaged (bent, dented).Probable root cause: improper storage conditions, improper handling, sterilization process not effective, improper reprocessing.The device manufacturer date is not known.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.(b)(4).
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Event Description
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It was reported the device contributed to patient infection.
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Search Alerts/Recalls
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