The company representative was able to resolve the reported event remotely with the customer.However, as there was no on site assessment, the reported events could not be confirmed or replicated.The company representative informed the customer that the surgical mode may switch to the next mode due to the footswitch.The company representative explained that this can be due to stepping on the footswitch¿s heel switch and not being aware of footswitch settings, not due to a malfunction of the system.The customer has not reported any further issues relating to this reported event.A system non-conformance based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.No similar complaints were reported for the product lot/batch/serial under investigation.The root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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