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Model Number 381121-32 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse powered on the integrated electrosurgical unit (iesu) and the u-02 error returned.The field service engineer (fse) replaced the iesu to resolve the issue.The system was tested and verified as ready for use.Isi received the part(s) involved with this complaint and device evaluation is in progress.The failure analysis (fa) investigation has not yet been completed and no findings are available.A follow-up mdr will be submitted if additional information is received.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.The event was verified upon troubleshooting with the customer.A system review was performed.Per the review, a hysterectomy ¿ benign (gynecology) procedure was performed on (b)(6) 2022 on system (b)(4).A review of the site's system logs for the reported procedure date was conducted.Investigation revealed the following possible related system errors: error u-02 ¿ iesu error no image or procedure video was provided for review.This complaint is considered a reportable event due to the following conclusion: the system was in an unacceptable state after the start of the procedure as the iesu would not function.While the surgeon was able to continue with the procedure robotically with a backup generator, the reported issue could be indicative of a system functionality problem that results in the system being in an unacceptable state.Additionally, a field service evaluation resulted in the iesu being replaced.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 conversion/abortion.
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Event Description
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It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the customer observed the integrated electrosurgical unit (iesu) had no power.The customer stated they had a u-02 error and had restarted several times with no change.The customer brought in another generator to complete the case.The technical service engineer (tse) had the site remove power from the iesu and disconnect the foot pedal cables with no change.The site continued with the procedure and requested the field service engineer (fse) to follow up.The procedure was continuing as planned with no reported 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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Additional information found in: g3, g6, h2, and h3 evaluation information found in: h6 and h10 intuitive surgical, inc.(isi) received the part(s) involved with this complaint and completed the device evaluation.The unit was returned for failure analysis and the reported failure or error u-02 was not confirmed.The unit was placed on an in-house system and was run in normal mode.The unit energized and cauterized and all ports recognized instruments.The unit will be sent the original equipment manufacturer as a safety precaution for further investigation.
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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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