MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI X; PATIENT SIDE CART, 4-ARM

Model Number 380620-37

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported complications cannot be determined.While docking issues were alleged during the initial da vinci procedure, there was no report or allegation from the customer of a deficiency of a specific da vinci system, instrumentation or accessories associated with the reported incident.Therefore, there are no products expected for return to intuitive surgical, inc.(isi) for failure analysis evaluation.A follow-up mdr will be submitted if additional information is obtained.Site history review was conducted on 15-oct-2021 and found an additional complaint related to this event for the tenaculum forceps instrument pn: 470207-08 || ln: s10150401-0018 used in this procedure related by event date, instrument detail, and instrument last used date.It was alleged that the "tenaculum could not straighten to be pulled out of the trocar." intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis replicated/confirmed the reported event of "tenaculum could not straighten to be pulled out of the trocar." failure analysis found the primary failure of broken main tube to be related to the customer reported complaint.The instrument was found to have the main tube broken.A piece measuring proximately 0.141¿ x 0.102¿ was not returned with the instrument.The root cause of broken instrument main tube is typically attributed to user mishandling/misuse.Additional observations not reported by the site were also identified: the instrument was found to have mechanical indentations on the proximal clevis.No material appeared to be missing.The root cause of this failure is attributed to the user.The instrument was found to have a frayed pitch cable at the distal clevis hub.The root cause of frayed distal instrument pitch cables is attributed to a component failure.System error log review was conducted for procedure date on (b)(6) 2021 on system sl0645.An error 31010 was observed indicating that a sterile adapter sensor was missing on universal surgical manipulator (usm) 2.The sterile adapter was fully detected then lost one, but not both, sensors.An error 31009 was also observed indicating that instrument sensors were missing.A tool was fully detected on usm3, but then lost one or more, but not all, tool sensors for three or more seconds.The logs indicate that recognition errors were occurring on arm 2 and arm 3, and these errors may be related to the reported docking issues.These errors were observed before the system went into following mode allowing the surgeon to control the arms via system controls.There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.While not all reusable instruments, with uses remaining, used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against those instruments with exception of the tenaculum forceps instrument pn: 470207-08 || (b)(6) which was captured in a different complaint.No image or video clip for the reported event was submitted for review.This event is being reported due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient reportedly returned to the hospital following due to vaginal cuff bleeding and an abscess on the vaginal cuff.The surgeon alleged that a da vinci product caused/contributed to this event, however, the cause of this injury is currently unknown.Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.Information for the blank fields is not available.It is unknown if the initial reporter submitted a report to the fda.

Event Description

An intuitive surgical, inc.(isi) clinical sales representative (csr) was informed, via the console surgeon, that after a da vinci-assisted hysterectomy procedure on (b)(6) 2021, the patient returned to the hospital on an unspecified date with vaginal cuff bleeding due to an alleged vaginal cuff abscess.It was reported that in the initial da vinci procedure, the staff reattempted docking the trocars four times and the surgeon believes that the isi system/product(s) may have caused or contributed to the patient injury.Intuitive surgical, inc.(isi) performed multiple follow-up attempts to obtain additional information.However, as of the date of this report, no further details have been received.

• Brand Name: DAVINCI X
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12764675
• MDR Text Key: 284900449
• Report Number: 2955842-2021-11449
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380620-37
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female