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Model Number 480422-01 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a da vinci assisted low anterior resection surgical procedure, the insulation on the branches (jaws) of the vessel sealer extend instrument was found broken (melted/thermal damage).The procedure was completed with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has requested that the vessel sealer extend instrument be returned for evaluation, however it has not yet been received.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 and evaluated and/ or if additional information is received.No image or video was provided for review.A review of the instrument log for the vessel sealer extend instrument cannot be performed at this time because a full instrument lot sequence number was not provided by the customer.This complaint is being reported based on the following conclusion: it was alleged that the vessel sealer extend instrument exhibited signs indicative of thermal damage with no evidence or claim of user mishandling or misuse.At this time, it is unknown what caused the thermal damage to occur.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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Manufacturer Narrative
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Intuitive surgical, inc.(isi) has received the vessel sealer extend instrument associated with this complaint and completed investigations.Failure analysis investigations could not replicate nor confirm the customer reported complaint that the insulation on the branches (jaws) of the vessel sealer extend (vse) instrument was found broken damaged.Visual inspection of the vse instrument found no signs of thermal damage at the grips on the distal end.The ceramic dots were inspected and all were present.The conductor wires were inspected, no damage was observed.The vse instrument passed an energy delivery test.There was no problem detected for the customer reported complaint.The vse instrument also was found to have several engagement failures based on remotefe log reviews.The engagement failures were not replicated during in-house testing.The instrument was also found to have an initialization failure based log review.The failure was not replicated in-house.The vse instrument was installed onto the in-house system multiple times and passed each time without issue.
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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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