The tip cover accessory will not be returned for evaluation as it was discarded by the customer.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow up mdr will be submitted if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci-assisted prostatectomy procedure, it was alleged that the tip cover accessory fell off the monopolar curved scissor (mcs) instrument and into the patient and was retrieved.Although, no patient harm was reported, at this time it is unknown what caused the tip cover accessory to fall inside the patient.
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It was reported that during a da vinci-assisted prostatectomy procedure, the tip cover accessory installed on a monopolar curved scissor (mcs) instrument had fallen off the instrument as it was being removed from the trocar and fell inside the patient.The surgeon was able to retrieve the tip cover accessory and confirmed there was no damage or fragment(s) missing from the tip cover accessory.There was no report of a patient harm, adverse outcome or injury.
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