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Model Number 380652-50 |
Device Problem
No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The field service engineer (fse) confirmed with the customer that there were no issues on the following case.No site visit was conducted.The system was working properly and no additional action was required.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.A review of the system logs was performed.Per the review, the following was confirmed: system sk4260, event date (b)(6) 2022 and procedure name - inguinal hernia.Furthermore, a review of the site's system logs for the reported procedure date was conducted by technical support.Investigation revealed the following possible related system errors: 31010|sterile adaptor sensor missing on usm3.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: a usm was abandoned after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.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.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.Blank mdr fields: follow-up was attempted, but patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.
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Event Description
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It was reported that during a da vinci-assisted inguinal hernia surgical procedure, arm 3 stopped working, technical support was contacted and the technical service engineer (tse) was informed by the customer that the surgeon could not take control of arm 3.Prior to the call, the customer stated that they moved the instrument to arm 4 and completed the case.The tse asked if the surgeon might have hit the arm swap pedal at the surgeon side cart (ssc), which would have changed the master tool manipulator (mtm) association from arm 3 (instrument installed) to arm 4 (no instrument installed) the customer was not sure.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and patient demographic information was requested, but not provided.
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Search Alerts/Recalls
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