The complaint is under investigation.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.
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Unfortunately, since the involved trocar was not returned after multiple requests, no physical examination could be performed to confirm the reported leakage and to determine its cause.Device history record review revealed no deviations and a database search showed that no similar complaint have been reported on this specific lot previously.Please note that, due to an increase of closure valve related complaints on the aveta trocar in 2022, a broader investigation was initiated.Subsequent to the initial investigation, a preliminary corrective action was implemented in (b)(6) 2022 to reduce similar issues.Please note that a thorough investigation to determine further actions to improve the aveta trocar is currently ongoing.Though a product failure could not in fact be confirmed for this particular case, we regret the customer's unfortunate experience with our product and compensation will be provided.Going forward, please make sure that all product involved in the event is returned, so that a proper complaint investigation can be conducted.In 2022 an increase in complaint rate was observed, which triggered a detailed investigation of the manufacturing process.As a result the dry time was increased, as this was considered the cause of the increase in complaints observed.Per ecf 2022-390, as a preliminary corrective action, a change was initiated to increase the drying time between glue application and next steps of assembly.The change was implemented with an update of all relevant work instructions.A thorough investigation to determine further actions to improve the aveta trocar is currently ongoing per ecf 2023-249.The analysis includes all complaints with failure modes ci-closurevalve-leakage and ci-closurevalve-defect-removal related to comparable trocar systems (distribution figures up to and including 25-04-2023).
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