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Model Number 380614-16 |
Device Problems
Defective Component (2292); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed during field evaluation.The fse reviewed the log and identified error 824, indicating the insufficient psc battery power.The four led battery indicators were flashing red.The battery box was replaced to resolve the issue.The system was tested and verified as ready for use.Intuitive surgical inc.(isi) received the battery box for failure analysis investigation, however, the investigation is still in progress.Therefore, the root cause of the customer reported failure has not been determined.A follow-up mdr will be submitted to the fda once the failure analysis investigation has been completed and/or if additional information is received.Site history review: a review of the site's complaint history does not show any additional complaints related to this product and/or this event.Image/video review: no image or video clip for the reported event was submitted for review.System log review: no further review is required as the logs are reviewed/analyzed as part of the tse and fse's investigation.Technical review: no further review is required as the system was tested and verified to meet manufacturer¿s specifications at the completion of a field service repair.The replaced part was returned for failure analysis to determine the root cause of the reported issue.Based on the information provided at this time, this complaint is being reported due to the following conclusion: a da vinci system malfunction occurred, rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.
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Event Description
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It was reported that during a da vinci-assisted surgical procedure, error 86 occurred while driving the patient side cart to the patient.The customer reported that the system started up normally, and the patient side manipulator was draped and deployed with no issues.The field service engineer was contacted for troubleshooting assistance, and the fse had the customer check the power source.The psc battery had four flashing red leds.The customer performed a power cycle, but the error persisted.The fse noted all possible troubleshooting steps were exhausted, but the issue could not be resolved.The customer requested the fse to come on site to inspect the system.The procedure was converted to laparoscopic surgery with no reported injury.
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Manufacturer Narrative
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Additional information can be found in the following field(s): g4, g7, h2, h3, h6, and h10.4307 - intuitive surgical received the battery module involved with this complaint and completed the device evaluation.The reported complaint was confirmed during failure analysis.The battery voltages were measured to be 26.14v overall, 13.11v for battery 1 and 13.03v for battery 2.The battery date is 12-june-2015.The expected battery pack voltage is 27.60v (2.30 volts/cell) when full and on the float charge.When empty with no charge or load on the battery, the voltage is expected to be 23v (1.93 volts/cell).The battery was installed into the pca system and it failed at power up with error 824, indicating low voltage.The unit failed on the bbm test fixture.Upon visual inspection, the battery was in good condition.Based on the additional information provided, this complaint remains reportable due to the following conclusion: a da vinci system malfunction occurred, rendering the da vinci system unavailable for use after the start of a surgical procedure.Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.
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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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