The instrument will not be returned for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed.No related system errors were found to have occurred during the surgical procedure.Based on the current information provided, this complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, fragments from the mcs instrument broke off and fell inside the patient.Although, all fragments were retrieved and no additional surgical intervention was required at this time it is unknown what caused the instrument breakage to occur.
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It was reported that during a da vinci-assisted inguinal hernia repair procedure, the black band on the monopolar curved scissors (mcs) instrument allegedly broke off, fell inside the patient, and was retrieved during the same procedure.According to the initial reporter, a robotics coordinator, the mcs instrument is not available for return to intuitive surgical, inc.(isi) for evaluation.On 04-jun-2018, isi contacted the initial reporter and obtained the following information regarding the reported event: she was not present during the surgical procedure.She was informed that all fragments from the mcs instruments were retrieved and no post-operative complications have been reported.The initial report confirmed that the instrument issue was identified at the end of the surgical procedure.On 04-jun-2018, isi also contacted the isi clinical sales representative (csr) who was present during the surgical procedure.The csr indicated that the surgical staff did not notice any issues with the use of the mcs instrument during the surgical procedure.There was no resistance upon removal of the mcs instrument through the cannula.No post-operative complications have been reported to his knowledge.The csr indicated that he instructed the site to return the mcs instrument to isi for evaluation.
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