Based on the current information provided, the root cause of the customer reported failure mode cannot be determined as the instrument was discarded by the site and is not available for evaluation.If additional information is received, a follow-up mdr will be submitted.A review of the site's complaint history shows related complaints patient identifier (b)(6) which documents the vse issues that occurred in the second case (b)(6) 2022.And patient identifier (b)(6) which documents the vse issues occurring in the first case (colostomy closure) (b)(6) 2022.The logs were reviewed by intuitive surgical, inc.(isi) advanced failure analysis engineer (fae) and the following findings were obtained: there are no errors recorded during the use of this vse in the e-100 logs.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: it was reported that tissue was stuck on the vessel sealer extend instrument's grips.Medical intervention may be required in the event that an moving instrument mechanism within an instrument entraps tissue and causes damage.At this time, it is unknown what caused the device entrapment issue to occur.The surgeon confirmed that there was no bleeding or insufficient sealing.Blank mdr fields follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
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It was reported that during a da vinci-assisted right hemicolectomy procedure, the vessel sealer extend (vse) was sticking to tissue.The same vse was used to complete the procedure robotically.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following information: during the right hemicolectomy procedure (b)(6) 2022.Fatty tissue was sticking to the jaws of the vse and the surgeon would remove the instrument by wiggling the tissue off.The surgeon did not have to cut tissue to release the instrument, nor do any tissue repairs.There was no bleeding or insufficient sealing seen.The same instrument was used to complete the procedure.The bedside assist cleaned the jaws properly each time they removed the vse instrument.There were no post-operative complications seen.Isi followed up with the clinical sales representative (csr) and obtained the following information: the vse have been discarded.
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