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Model Number 480440-05 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a da vinci-assisted surgical procedure, the synchroseal instrument was unable to cauterize and be opened.The procedure was completed with no reported injury.On april 5, 2022, intuitive surgical (is) contacted the reporter and obtained the following additional information regarding this event: the instrument was inspected prior to use.The instrument had been in use for approximately 10 minutes.The jaws could not be separated from each other outside the tissue.The target tissue was uterus.It is unknown how the jaws were able to be opened.Further information has been requested from the reporter.However, no additional details have been received as of the date of this report.
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Manufacturer Narrative
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An rma has been issued to the customer requesting to have the instrument returned; however, isi has not yet received the synchroseal 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.A review of the device logs for the synchroseal (part# 480440-05 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the synchroseal was last used on (b)(6) 2022 via system serial# (b)(4).There were 0 uses remaining after this last usage.This device is a single-use instrument and therefore only has one use allotted to it.This reported issue occurred on the instrument's only allotted usage.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No photo or video was provided by the site for review.This complaint is being reported due to the following conclusion: it was reported that the instrument grips did not open and/or were clamped and could not be opened with the use of the emergency grip release function.Medical intervention may be required in the event that the synchroseal fails to unclamp from tissue when commanded by the user or system.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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Refer to h10/h11 for follow-up information.
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Manufacturer Narrative
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Intuitive surgical, inc.(isi) received the synchroseal instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations confirmed and replicated the customer reported complaint.The synchroseal instrument was found to have dislodged grip tips.The inner white part of the grip tip came dislodged off the outer grip tip and there was no missing material.The root cause of this failure is attributed to mishandling/misuse.A review of the log shows no errors.The synchroseal instrument was transferred to engineering for further investigation and the primary fa was confirmed.The inner white part of the grip tip was confirmed to have become dislodged.However, the root cause attributed to a component failure rather than mishandling/misuse.
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Search Alerts/Recalls
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