Intuitive surgical, inc.(isi) has not received the permanent cautery hook instrument for evaluation.Therefore, 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.A review of the site's complaint history does not show any additional complaints related to this product.An image of the permanent cautery hook (pch) instrument was received from the customer.A review of the provided image was consistent with the report of a plastic piece falling off the instrument.Further details regarding the failure mode will be obtained through the failure analysis investigation upon the return of the instrument.A review of the system log and instrument log was performed.The instrument was last used on (b)(6) 2022 on system (b)(4).The permanent cautery hook has 2 uses remaining after the last use.The permanent cautery hook has a maximum of 10 uses.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a permanent cautery hook (pch) instrument broke and a plastic piece was missing.The plastic piece fell inside of the patient and the surgeon was unable to find a missing piece of ultem.It is unknown what caused the breakage to occur.Additionally, it is unknown if the fragment was retrieved or if the fragment remains inside the patient's anatomy.
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It was reported that during a da vinci-assisted hysterectomy surgical procedure, a permanent cautery hook (pch) instrument broke and a plastic piece was missing.The plastic piece fell inside of the patient and the surgeon was unable to find a missing piece of ultem.The caller indicated that the surgeon tried to find the piece but at the time of the call had not found it.The intuitive surgical, inc.(isi) technical support engineer (tse) noted that this piece was made of ultem and is not radiopaque.The surgeon was going to determine how to proceed.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
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