Intuitive surgical, inc.(isi) will not be receiving the tip cover accessory as it was discarded.Thus, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the tip cover accessory fell inside the patient.Although, the tip cover was retrieved and no patient harm, adverse outcome or injury was reported, it is unknown what caused the accessory to fall inside the patient.
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It was reported that at the end of a da vinci-assisted low anterior resection procedure, as the customer undocked the system and removed the monopolar curved scissors (mcs) instrument, the msc tip cover accessory was missing.The surgeon believed the tip cover accessory got stuck in the cannula as the instrument was removed.The surgeon then introduced an unspecified grasper instrument through the cannula and the tip cover accessory fell inside the patient.The tip cover accessory was immediately retrieved, inspected and confirmed it was intact.The procedure was completed and there was no report of harm, adverse outcome or injury.The tip cover accessory was discarded by the customer.
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