Related to tw (b)(4).Summary: the hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech has pitting corrosion / pitting after 4 weeks of preparation.Mechanical cleaning is carried out with the product thermosept xtra 0.5% from (b)(4).No implantation or use on the patient, but pitting / rust after processing in the washer-disinfector.
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Trackwise (b)(4).Updated section: g4, g7, h2, h3, h6, h10.Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure mode.Historical data analysis: (4109/213/67) there were 02 additional similar complaint(s) reported for the reported failure mode and the reported serial number.A review of the product complaint trend data was performed for the months of jun 2021¿ through ¿sept 2021.The review does not identify an increasing trend or an adverse trend for three consecutive months for the product family and the failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device : (10 &13 & 22) the device was returned to the factory for evaluation on 11/15/2021.An investigation was conducted on 11/23/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.Evidence of corrosion was observed on the engraved numbers on the device.No other visual defects were observed.Based on the returned condition of the device, the reported failure "corroded" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.
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