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Model Number 470183-14 |
Device Problems
Thermal Decomposition of Device (1071); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that during central processing that, the plastic end of the distal tip of the permanent cautery hook instrument is burned.There was no report of patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the damage was identified after reprocessing.The instrument was inspected before being reprocessed prior to the event.The damage to the instrument was noted in the sterile processing department (spd).
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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 thermal damage to be related to the customers reported complaint.The instrument was found to have thermal damage on the monopolar yaw pulley.The conductor wire insulation was not damaged.The conductor wire was not broken.The instrument passed the electrical continuity test.The root cause of thermal damage on the instrument monopolar yaw pulley is typically attributed to mishandling and misuse.Additional finding not reported by site was that the instrument was found to have thermal damage on one of the distal clevis ears.The root cause of thermal damage on the distal clevis is attributed to misuse.A review of the instrument logs for the permanent cautery hook instrument (470183-14/k10220510 0052) associated with this event was performed.The instrument was last used on (b)(6) 2022.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.Failure analysis confirmed the issue and the cause is attributed to mishandling and misuse.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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Search Alerts/Recalls
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