Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.Visual inspection identified damaged conductor wire insulation.The instrument was tested and passed electrical continuity.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No procedure video or image was submitted to isi for review.A review of the instrument log for the fenestrated bipolar forceps instrument lot# n13200113 /sequence 0428 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2020 using da vinci system sk0633.The instrument had 1 remaining life with no subsequent use recorded.The customer reported event stated the issue was observed during reprocessing on (b)(6) 2020.This information indicates that the instrument was reprocessed the same day after the procedure.The fenestrated bipolar forceps instruments are multiple-use electrosurgical endoscopic instruments with a grasping tip to be used in conjunction with the da vinci system and an external electrosurgical unit (esu).The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).This complaint is a reportable event based on the following: it was reported that during central processing, inspection identified damage on the fenestrated bipolar forceps instrument cable.There was no report of patient involvement.The customer reported complaint does not itself constitute an mdr reportable event; however, this complaint is being reported because failure analysis of the fenestrated bipolar forceps instrument found conductor wire insulation damage with a passed electrical continuity test.Although there was no arcing reported or seen through analysis, and there was no patient injury reported, if this failure were to recur, it could result in an adverse event.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument had 1 remaining usable life, therefore, had not expired.
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It was reported that during central processing, inspection identified damage on the fenestrated bipolar forceps instrument cable.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: no reported instrument issue was observed when the instrument was last used for a procedure on (b)(6) 2020 using da vinci system sk0633.
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