Unfortunately, since the involved trocar was not returned, no physical examination could be performed.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported on this specific lot.However, based on other similar complaints on other lots of this product a detailed investigation of the manufacturing process revealed that when the drying time of the applied glue on the cap of the product is too short for the volume of glue dispensed, valves may in some cases become sticky.Subsequent to the investigation, the drying time was increased as a corrective action to prevent similar issues.Therefore, the most plausible rootcause of this complaint is considered a sticky valve due to insufficient drying time of glue in relation to the volume of glue applied.In 2022 an increase in complaint rate was observed, which triggered a detailed investigation of the manufacturing process.As a result the dry time will be increased, as this was considered the cause of the increase in complaints observed.Per ecf 2022-390, 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.As of (b)(6) 2022 all aveta trocars are assembled in accordance with the updated work instructions.The analysis includes all complaints with failure modes ci-closurevalve-leakage and ci-closurevalve-defect-removal related to comparable trocar systems.
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