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

Model Number 380652-43

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 10/04/2023

Event Type  Death  

Manufacturer Narrative

Although no specific information is available, a confirmed procedure date and surgeon name were provided.The initial hearsay information statement to the intuitive surgical clinical sales representative regarding being unsure about bleeding or a potential conversion to open surgery has not been confirmed.An additional attempt to substantiate the information is in process.A review of the system logs for the reported procedure date and the 5 subsequent procedures performed with the system found that there were no errors that likely would have contributed to an adverse event.Device history record (dhr) review for the device(s) used during the reported event did not identify any non-conformances that would be related to an adverse event.The instruments noted below were used during the reported procedure.Review of the instrument logs found that the following multiple use devices were used in subsequent procedures after the event date with no reported complaints and have lives remaining: endoscope, monopolar curved scissors, fenestrated bipolar forceps, large needle driver, prograsp forceps.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that a patient who underwent a partial nephrectomy expired following the surgery.The details of the procedure, the patient¿s post operative course, and cause of death were not provided.Therefore, insufficient information is available to ascertain if any intuitive surgical products or instruments contributed to this event.

Event Description

An intuitive surgical clinical sales representative reported that the operating room director informed him that a patient had expired.The patient had undergone a da vinci-assisted partial nephrectomy procedure.The only information provided was that the patient was transferred to another hospital and expired post-operatively.Attempts to contact the operating room director have been unsuccessful.The surgeon declined to provide additional information.

Manufacturer Narrative

The intuitive surgical clinical sales representative was able to confirm additional information about the event with a nurse who was present for the procedure.It was reported that the patient's anatomy was abnormal as there were two renal arteries present.The robot was used to clamp both arteries with bulldog clamps.Indocyanine green (icg) was utilized to measure blood flow to the kidney after clamping; the blood flow was still present so both bulldogs clamps were removed for readjustment when the patient started to bleed.The surgeon was able to slow down the bleeding robotically.It appeared that the source of bleeding was possibly a renal artery injury.The procedure was then converted to open laparotomy to address the bleeding.A cardiovascular surgeon was utilized to assist with the repair of the artery.Bleeding was able to be controlled by suturing the artery during the laparotomy.The patient was then transferred to a larger sister hospital for higher acuity of care.The patient expired within 24 hours.The clinical sales representative also discussed the events with the surgeon.The surgeon reported that no da vinci errors or issues occurred intra-operatively, and declined to discuss any additional 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: 18051893
• MDR Text Key: 327123932
• Report Number: 2955842-2023-19868
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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: 380652-43
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2018
• 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: Male