The cannula seal accessory will not be returned to isi for failure analysis investigation as it was confirmed that it was discarded.Therefore, the customer reported failure has not been been determined.If additional information is received, a follow-up mdr will be submitted to the fda.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure a fragment from the cannula seal accessory broke off and fell inside the patient.The fragment was retrieved, however, at this time it is unknown what caused the breakage to occur.
|
It was reported that during a da vinci-assisted inguinal hernia repair procedure, a piece of an unspecified cannula seal accessory broke off and fell inside patient and was retrieved.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) obtained the following additional information from the initial reporter: the initial reporter confirmed that the broken fragment was retrieved immediately with no additional medical intervention.It was also confirmed that the cannula seal accessory would not be returned to isi.
|