An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The left screen in the high resolution stereo viewer (hrsv) of surgeon side console 1 was replaced to resolve the issue of black image during surgery.The system was tested and verified as ready for use.Isi has not yet received the replaced component for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.No image or procedure video was provided.Fse reviewed the system logs at the time of the call into technical support.The logs confirmed the reported errors.This complaint is being reported based on the following conclusion: system unavailability after the start of a surgical procedure caused the procedure to be converted to another da vinci and may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.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.Blank mdr fields: follow-up was attempted, but the missing patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date for section is not applicable.Field is blank because the product is not implantable.Information for the blank fields in section is not available.Fields are not applicable.
|
It was reported that during a da vinci assisted prostatectomy surgical procedure, there was no signal on one eye of surgeon side console (ssc) 1.The caller (doctor) indicated the display was fine on ssc 2.Due to the surgery being in progress, the surgeon did not want to troubleshoot the issue.Intuitive surgical inc.(isi) technical support engineer (tse) could not view live system logs.The procedure was completed with no patient injury.Additional information was obtained on 07-dec-2021.The tse reviewed system logs and confirmed that surgeon side console (ssc) 2 was used to complete the procedure.The isi field service engineer (fse) confirmed that the ssc1 was down during the surgery and a switch to ssc 2 was required to complete the procedure.
|
D14- intuitive surgical, inc.(isi) has received the hrsv (high resolution stereo viewer) associated with this complaint and completed investigations.Failure analysis investigations could not replicate nor confirm the customer reported complaint.When the hrsv was installed on an in-house system and powered on, video was seen on both eyes of the surgeon side console.The unit ran through a series of power cycles and burn-in for multiple hours and no issues were observed.
|