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Model Number 380652-48 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/24/2022 |
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.Fse replaced the universal surgical manipulator (usm1).The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the usm involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation could not replicate the customer reported complaint.However, the error was confirmed along with error 23007 via error logs/system logs.An error 23007 shows that degree of freedom (dof 3) was causing the error.The usm was tested on an in-house system and passed normal mode.The usm was also tested on a psc fixture test platform (pftp) and passed lissajous, sensors check, sine cycle, but failed the low-speed friction on the yaw.The yaw and pitch motor modules, harmonic drives and the joint 3 bearings will be replaced as a fix.The yaw and pitch housing flat flex cable (ffcs) will also be replaced as a precaution.No image or video was available for review.A review of the site's system logs for the reported procedure date was not conducted by technical support when the customer called for troubleshooting assistance as the onsite connectivity was not available at the time of event.An event verification confirmed the procedure was performed on the reported event date on (b)(6) 2022 on system sk3862.This complaint is considered a reportable malfunction event due to the following conclusion: the customer converted to laparoscopy after the start of the procedure due to an inoperable psc.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion.
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Event Description
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It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the customer was unable to drive the patient side cart (psc).There were no error messages.An intuitive surgical, inc.(isi) technical support engineer (tse) asked the customer to perform a system reboot, but the issue remained.Then the customer tried to move the psc auto/manual drive lever to manual.However, the psc was still not able to be moved.The customer checked for any obstructions and no obstructions were found.Then the system received an error message that arm 1 was not free to move and to check for obstructions.The customer moved arm 1 around, but the issue persisted.The tse recommended the customer to perform a hard system reboot with the breaker, but that was not possible as the procedure had already begun and the camera was needed.The procedure was converted to laparoscopy with no reports of patient injury.Isi followed up with the initial reporter and obtained the following additional information on 18-august-2022: the procedure was converted to laparoscopy as the patient side cart (psc) was not able to be docked after port placement.The procedure was completed laparoscopically and there was no report of patient injury.
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Search Alerts/Recalls
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