A review of the submitted image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae) on 18-nov-2020.The following additional information was provided: the image of the fenestrated bipolar forceps (fbf) instrument identifies a slight damage on the conductor wire insulation.No thermal damage confirmed.Isi received the fbf instrument involved with this complaint and completed the device evaluation.Visual inspection identified damage on the conductor wire insulation.It was confirmed that there was no missing material on the area of the damage.The known common cause of this failure is attributed to instrument mishandling and misuse.This observation is consistent with the fae's analysis of the submitted photograph.Additionally, a frayed grip cable at the distal end was found.This failure is attributed to component failure.The instrument was further tested and passed electrical continuity.A review of the instrument log for the fbf instrument lot# n1018071 /sequence 928 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2020 using system (b)(4).Instrument had 1 remaining usable life with no subsequent use recorded.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.This complaint is being reported as a reportable malfunction event due to the following conclusion: 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).It was reported that during central processing, the customer conducted an inspection and observed a damaged wire at the wrist of the fenestrated bipolar forceps instrument.Isi fae's analysis of the submitted photograph identified a slight damage on the conductor wire insulation.Evaluation by failure analysis confirmed the customer reported event.Fa identified damage on the conductor wire insulation with no missing material.The known common cause of this failure is attributed to instrument mishandling and misuse.The instrument was further tested and passed electrical continuity.The customer reported complaint does not itself constitute an mdr reportable event; however, this complaint is being reported because damage to the conductor wire within the instrument could lead to unintended electrical discharge at a location other than intended.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 davincisurgical system.The instrument has 1 remaining usable life, therefore, had not expired.
|
It was reported that during central processing, the customer conducted an inspection and observed a damaged wire at the wrist of the fenestrated bipolar forceps instrument.No patient involvement was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information.There was no issue related to unintended energy discharge or arcing on the last recorded instrument usage ((b)(6) 2020 using system (b)(4)).
|