Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations did not replicate nor confirm the customer reported complaint.The fenestrated bipolar forceps instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.An in-house bipolar cautery cable was installed onto the instrument and was recognized by the system when plugged in.The instrument housing was removed from the back end and no damage was found.The instrument passed the electrical continuity and energy delivery tests.There was no problem detected for the customer reported complaint.There were additional observations not reported by the site and not related to the customer reported complaint.The fenestrated bipolar forceps instrument was found to have thermal damage on the bipolar yaw pulley.The instrument was found to have charring and localized melting at the grip base between the grips.The thermal damage to the yaw pulley is unrelated to the conductor wire.No insulation damage was observed.The conductor wire was not damaged or broken.The root cause of the thermal damage between grips instrument bipolar yaw pulley is typically attributed to mishandling/misuse, most commonly caused by insulation degradation and carbonized tissue creating a conductive path.A review of the instrument logs for the fenestrated bipolar forceps instrument (part number 470205-17 / lot number n13210510-0123) associated with this event has been performed.Per the review, the fenestrated bipolar forceps instrument was last used on (b)(6) 2022 via system (b)(4).The alleged instrument had 4 uses remaining after the last procedural usage.Isi has received the images of the broken fenestrated bipolar forceps instrument.The review of the provided image was conducted by an isi failure analysis engineer (fae) and obtained the following additional information: there does not appear to be any visible damage to the fenestrated bipolar forceps instrument tip or wires.This complaint is reportable malfunction event due to the following conclusion: failure analysis investigations confirmed thermal damage on the bipolar yaw pulley.The thermal damage finding is evidence of 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 fenestrated bipolar forceps instrument suddenly stopped producing electrical power.The customer replaced the instrument energy cable, but the issue persisted.The customer then replaced the fenestrated bipolar forceps instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.The fenestrated bipolar forceps is a 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).
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