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Model Number 471205-17 |
Device Problems
Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of yaw pulley thermal damage to be related to the customer reported complaint.During visual inspection the instrument was found to have thermal damage at the tip of the yaw pulley.The instrument passed electric continuity.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument released energy on several attempts.Additional observation related to customer reported complaint: the instrument was found to have damage to the conductor wire¿s insulation.Visual inspection found the wire exposed.As a result thermal damage occurred to yaw pulley.Root cause is attributed to a component failure.No image or video clip for the reported event was available for review.A review of the instrument log for the fenestrated bipolar forceps (471205-17 / n11200727-0042) associated with this event has been performed.Per logs, the fenestrated bipolar forceps was last used on 01-aug-2022 via system (b)(4) for a right hemicolectomy procedure with 4 lives remaining.The alleged event occurred on the 10th use of the instrument.This complaint is considered a reportable malfunction due to the following conclusion: during a da vinci-assisted right hemicolectomy surgical procedure, it was alleged that the fenestrated bipolar forceps instrument exhibited signs indicative of thermal damage.Failure analysis found the instrument had damage to the conductor wire's insulation and the wire was exposed.The damaged/broken conductor wire has potential for 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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Event Description
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It was reported that during a da vinci-assisted right hemicolectomy surgical procedure, the fenestrated bipolar forceps instrument was observed to have a plastic piece at the distal end melted.A backup instrument of the same kind was used, and the procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the customer to confirm that the distal portion was broken.It is unknown if the instrument was inspected before the procedure.
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Search Alerts/Recalls
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