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

Model Number 380652-33

Device Problems Device Slipped (1584); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Hemorrhage/Bleeding (1888); Unspecified Kidney or Urinary Problem (4503)

Event Date 02/24/2022

Event Type  Injury  

Event Description

It was reported that during a da vinci assisted radical hysterectomy with bilateral salpingo-oophorectomy and lymphadenectomy, the patient¿s left ureter was injured which led to a difficult postoperative course involving additional hospitalizations and multiple reoperations.The patient reports being told by the surgeon that while cauterizing a lymph node, he slipped on scar tissue and the left ureter was inadvertently burned requiring placement of a left ureteral stent.The patient stated that 2 weeks after being discharged, she experienced left-sided pain and was readmitted to the hospital with a urinary tract infection (uti).She was told the stent placed during the initial procedure was too small and so ¿it [urine] backed up and then i had a full-on kidney infection.¿ the original ureteral stent was exchanged for a larger size, with the plan being to perform a ureteral reattachment procedure at a later date after ¿everything had calmed down.¿ at some point, a nephrostomy tube was placed to allow the ureter to relax before reattachment to the bladder.The patient stated when the stent was removed, she went into septic shock which put her in icu for 3 days.The patient also reports suffering a stroke during the septic shock.Approximately 5 weeks later, she underwent an open surgical procedure to try and reattach the ureter to the bladder.However, the ureter was ¿destroyed¿, and a nephrectomy was performed.The patient also stated that she has multiple disabilities (e.G.Can't think straight or even drive", cannot take medications "due to just having one kidney", depression).

Manufacturer Narrative

A review of the site history found that there were no complaints received for this procedure from the hospital where the robotic surgery was performed.Additionally, a review of the procedure and instrument logs showed that the 0 degree endoscope and instruments used during the case (monopolar curved scissors, prograsp forceps, fenestrated bipolar forceps and large suture cut needle driver) have all been used in subsequent procedures with no relevant complaints received.A system log review did not reveal any system errors that would have caused or contributed to the reported event.Section h6, adverse event problem, additional health effect clinical code: annex code e233605 - septic shock.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Section b5 event description additional information: on (b)(6) 2023, the patient disclosed she suffers from chronic fatigue, and bladder damage from the event.Images associated with this reported event were submitted by the patient for review and depict exterior patient anatomy (foot, leg, hand) with lesions of unknown origin on the skin, along with a pelvic x-ray image with no patient identifiers and a ureteral stent in place.The video image lasts approximately 2 seconds, and is a view of an arm with an iv in place, and with similar skin lesions.The language describes an intraoperative injury to the left ureter during a da vinci gynecological (gyn) procedure which cannot be confirmed by video or image review.

• 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: 18116931
• MDR Text Key: 327881399
• Report Number: 2955842-2023-20206
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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: 10/12/2023

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: 380652-33
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• 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: 55 YR
• Patient Sex: Female
• Patient Race: White