Intuitive surgical, inc.(isi) has not received the synchroseal instrument for evaluation because the customer noted that it would not be returned.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.In addition, a review of the instrument log for the synchroseal instrument (part # 480440-05/lot# l90200927 0063) associated with this event has been performed.Per logs, the instrument was used on (b)(6) 2021, on system (b)(4).This is a single-use instrument.No image or video clip for the reported event was submitted to isi for review.This event is being reported based on the following conclusion: it was alleged that the instrument may have arced during the procedure with no evidence or claim of user mishandling or misuse.The allegation is related to the potential for electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
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It was reported that during a da vinci-assisted surgical procedure, the intuitive surgical, inc.(isi) clinical sales representative (csr) called in stating that the e-100 generator powered off when using with a synchroseal instrument.The technical support engineer (tse) explained it could happen when the instrument tips were damaged or there was arcing.The tse advised to refer to the message for the cause and replace the instrument.The procedure was continuing as planned with no reported injury.Later, the csr called back to inform that there was damage to the blade of the synchroseal and he suspected the thin tissues that were sealed contributed to the damage.Intuitive surgical, inc.(isi) followed up with the site on 18-oct-2021, including the surgeon, and obtained the following additional information regarding the reported event: the synchroseal instrument was reportedly inspected prior to use, and no issues were noted.The instrument performed as intended until the reported event.It was unknown if arcing from the instrument was observed, but arcing contained within the jaws of the instrument was not reported.Sealing was completed and the jaws of the instrument did not come in contact with any other objects when the issue occurred.Additionally, the jaws were not immersed in a liquid or contaminated by carbonized tissue (bio debris) prior to or during the sealing cycle.There was no adverse effect to the thin tissue.The issue was resolved by rebooting the generator.The instrument is not available for return to isi for evaluation.There are no photographic images of the device or a video recording of the procedure.Information regarding patient demographics, relevant testing, and medical history were requested however, the reporter was not able to provide that information.
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