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Model Number 470205-17 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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An rma has been issued to the customer requesting to have the isi device returned; however, isi has not yet received the fenestrated bipolar forceps instrument for evaluation.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 obtained.Product and event verification: a review of the device logs for the fenestrated bipolar forceps (part# 470205-17 | lot/serial# n132001060081) associated with this event has been performed.Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2020 via system serial# (b)(4).There were 9 uses remaining after this last usage.There was no photo or video provided by the site for 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 because a bipolar instrument with damaged conductor wire insulation could lead to inadvertent energy transmission to tissue other than intended via the exposed conductor wire.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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Event Description
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It was reported that during a da vinci-assisted surgical procedure, the customer stated that the fenestrated bipolar forceps (fbf) instrument was noted to have a broken cable.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) contacted the site to obtain additional information regarding this event.The only additional information provided was that it was the black cable that was broken.
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Event Description
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Refer to h10/h11 for follow-up information.
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Manufacturer Narrative
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Additional information can be found in the following section a and fields d10, g4, g7, h2, h3, h6, and h10.4307- intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation replicated/confirmed the customer reported complaint.Fa found the primary failure of broken conductor wire to be related to the customer reported complaint.The instrument was found to have a broken conductor wire at the yaw pulley.The conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test.No signs of thermal damage were observed.The root cause of this failure is attributed to a component failure.
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Search Alerts/Recalls
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