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Model Number 470183-14 |
Device Problems
Thermal Decomposition of Device (1071); Smoking (1585); Arcing (2583); 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 06/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has requested the permanent cautery hook instrument for evaluation, but the instrument has not yet been received as of the date of this report.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned for analysis and/or if additional information is received.A review of the procedure log with the information provided resulted in no additional information.In addition, the permanent cautery hook instrument information cannot be verified through the system log review at this time as it was not registered on the system.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was alleged that the instrument arced and smoked.The allegation could be related to the 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 liver resection surgical procedure, the surgeon observed more smoke from the permanent cautery hook instrument tip.The customer replaced the permanent cautery hook instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.Intuitive surgical, inc.(isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument was reportedly inspected prior to use, and no issues were noted.The instrument was in use for one hour up until the reported event.The customer observed arcing during the procedure.No evidence of thermal damage was identified after the arcing event.The surgeon activated monopolar energy with an external force triad generator and was dissecting tissue when the issue occurred.The electrosurgical generator unit (esu) settings were cut 30 and coag 40.The fenestrated bipolar forceps instrument was also in use at the time of the event.The instrument did not collide with any other instrument or tool during the procedure.The tip of the instrument did not come in contact with any other objects when the issue occurred.Additionally, the instrument tip was not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to energy activation.It was confirmed there was no patient harm, injury or adverse outcome.The instrument is available for return to isi for evaluation.No photographic images of the device or a video recording of the procedure are available.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) received the permanent cautery hook 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 the thermal damage at the weld on the monopolar yaw pulley to be related to the customer reported complaint.The instrument was found to have thermal damage on the monopolar yaw pulley at the weld.The electrical continuity test was performed and failed.The root cause is typically attributed to mishandling/misuse.There were additional observations not reported by the site and related to the primary failure.The instrument was found to have thermal damage on the monopolar yaw pulley.The root cause of this failure is attributed to mishandling/misuse.The distal end of the instrument was disassembled, and the instrument was found to have a broken conductor wire at the weld.The root cause of the broken conductor wire is attributed to device design.The instrument was found to have damage of the conductor wire¿s insulation.As a result, the internal wires were exposed.The root cause of this failure is attributed to a component failure.The instrument was found to have thermal damage on the conductor cap.The root cause of this failure is attributed to mishandling/misuse.
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Event Description
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Refer to h10/h11 for follow-up information.
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Search Alerts/Recalls
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