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Model Number CW-RBPBX |
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 02/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The primary packaging containing the cw-rbpbx has not been returned to the service center for evaluation for foreign material inside the package.Therefore, the exact cause of the reported event cannot be determined at this time.The original equipment manufacturer (oem) performed a device history record review for this product, and all records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of (b)(4) units were manufactured under this lot number, and there were no non-conformances, reported scrap, or reported process deviations related to the reported failure.(b)(4).Photographs of the primary packaging of the device containing the reported foreign material were received, an evaluation of the photos has not been initiated.Upon completion of the evaluation a supplemental report will be submitted.
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Event Description
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The service center received a report of one package of cyberwand probe set (model cw-rbpbx), lot number w1901098, that had foreign material inside the primary packaging.It was reported that the charge nurse was performing incoming inspection of product, when it was observed that the primary packaging for the cw-rbpbx contained lint/foreign material, breaching the sterility of the product.It was reported that the package was stored on a shelf and was not torn, dented, or breached to the outside environment.The package was removed immediately from service and did not come into contact with any patient.The remaining inventory was inspected and no further packages were found to contain foreign material.Photographs of the received condition device have been received at the service center for evaluation.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the device evaluation.The customer returned a cw-rbpbx cyberwand probe and it was evaluated for the report of "it was discovered there was lint found in the sterile packaging for the cw-rbpbx." the device was returned in the original sealed tyvek pouch.Upon inspection of the received device the complaint was confirmed as lint is present inside the sealed pouch.A definitive root cause for the reported problem could not be determined.This product is no longer manufactured by cybersonics inc.For this reason, no additional corrective action will be taken at this time.Olympus will continue to monitor the field performance of this product through trending.
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Search Alerts/Recalls
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