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

Model Number 380652-40

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Rectovaginal Fistula (4509); Unspecified Tissue Injury (4559)

Event Date 05/28/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the alleged operative complications cannot be determined due to insufficient information.Intuitive has not been provided with any relevant medical records to date.A site history review found that there were four (4) hysterectomy procedures performed on the reported date of (b)(6) 2021 by the same surgeon using a da vinci system.The hospital has two da vinci systems (serial numbers (b)(6)); 2 cases were completed with each of the systems that day.There is insufficient information to determine which of the 4 procedures represent this event or which da vinci system was used during this procedure.There were no reports of any da vinci product issues received by the site healthcare professionals for any of the noted procedures.An advanced system log review for the reported event date of (b)(6) 2021 was performed for both da vinci systems used for the hysterectomy procedures performed by the surgeon.The same conclusion that there was nothing found in the logs to suggest a fault with the da vinci systems was reached for both devices and all 4 procedures.Additionally, the logs for the 5 procedures that were completed before and after this procedure date were reviewed and there were no other events captured that would suggest a fault with the systems.Review of the system instrument logs for the reported procedure date for both da vinci system found no related errors occurred during the procedures that would have likely caused or contributed to the reported event.All reusable instruments that had remaining lives were used in subsequent procedures with no complaints received for any of the instruments.One single use device, and two devices with zero lives remaining were presumably discarded.Review of the available event information performed by an intuitive surgical medical safety officer (mso) concluded that the patient in this report underwent a hysterectomy.It is unknown if this was for a benign or malignant process.The extent of the dissection and how it may have involved adjacent structures was not provided.A rectovaginal fistula is alleged to have developed postoperatively.Monopolar cautery was allegedly used during the case but how and when it was used or how it may have contributed to this potential complication has not been provided.Based on the information provided in the summary of events, insufficient information is available to determine if any intuitive surgical products or instruments contributed to this event.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

Event Description

As part of a legal complaint, it was alleged that, at an unspecified time post-procedure after a davinci robot-assisted hysterectomy procedure, the patient complained of fever and pain, and was expelling feces via the vagina.It was further alleged that the patient was admitted to the intensive care unit and was subsequently diagnosed with colorectal-vaginal fistula(s).The legal complaint alleges that during the procedure, subsequent to the use of monopolar cautery, the patient¿s internal organs were burned, fused together and otherwise damaged, requiring a permanent ileostomy and several extended hospital stays.The patient allegedly continues to experience pain and extended periods of disability.No additional information was provided.

Manufacturer Narrative

A copy of the surgeon¿s operate note was provided for review.The procedure was documented as a ¿robotic-assisted laparoscopic hysterectomy, bilateral salphingo-oophorectomy, pelvic washings with bilateral pelvic and periaortic lymph node dissection and lysis of adhesions (30 minutes out of a 90 minute procedure).¿ the operative note did not document any issues or complications during the procedure or with any of the medical devices used.The post-operative diagnosis was ¿grade 3 endometroid adenocarcinoma of the endometrium with pelvic adhesions¿.Davinci products identified as used during the procedure were the fenestrated bipolar grasper, camera (endoscope), monopolar curved scissors, vessel sealer, needle driver and prograsp forceps.There was nothing in the operative report that states or indicates any issues with the davinci system, instruments or accessories.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• 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: 17619881
• MDR Text Key: 321917854
• Report Number: 2955842-2023-17999
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-40
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 72 YR
• Patient Sex: Female