It was reported the patient received a smart piston implant which crimped both during and post procedure resulting in another procedure at another date.According to the report, the problem found when the user used it for a patient who had undergone stapedectomy on (b)(6) 2022.According to the report, during the procedure, customer had to open a second implant as the first one crimped back.However, later on, this patient came in for a revision stapededtomy on (b)(6) 2022 and same issue was observed.The customer replaced the implant with big easy (third party device) according to the report, patient had the stapedectomy on the other side on (b)(6) 2022 and a big easy piston was used for the procedure.The intended procedure was completed.No injury or harm was reported.This event includes two reports.Report with patient identifier (b)(6) smart piston model 70145928 lot sm960548 - crimped smart piston (during procedure and was replaced with second smart piston).Report with patient identifier (b)(6) smart piston model 70145928 lot pr966762.- crimped smart piston (fully implanted).This report is for report with patient identifier (b)(6) smart piston model 70145928 lot sm960548.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it was determined that there was no manufacturing, material or processing related cause for this failure mode.The likely root cause has been determined to be environmental exposure (temperature/storage) of the device, which resulted in the device activating (crimping) before being exposed to the 65 degrees celsius temperature.It is unlikely that the device left the facility damaged.Therefore, the damaged device is most likely a result of transportation and/or storage of the device.This supplemental report includes information added to g2.Olympus will continue to monitor field performance for this device.
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