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

Model Number 380652-46

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/01/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

Event Description

It was reported that during a da vinci-assisted hiatal hernia-paraoesophageal surgical procedure, an instrument was unable to be removed from the trocar and the universal surgical manipulator (usm) 4 while needing to undock due to the patient status was becoming unstable.The patient experienced a decline in their end-tidal co2, blood pressure was rapidly decreasing however, their heart rate remained stable.The robotic portion of the hiatal hernia was almost complete, when the status change occurred.The surgeon then ensured all robotic instruments were not holding onto any tissue and then had the bedside assist emergently undock the instruments and the patient side cart (psc).It was unclear what caused the patient's status change as the entire procedure had been successful and there there were no errors or complications, specifically with any da vinci products.During the undocking process the bedside assistant was unable to remove the tip-up fenestrated grasper instrument from the trocar and the universal surgical manipulator (usm) the surgeon was unclear as to why this would have occurred.It was discussed that as she stepped away from the surgeon side console (ssc) the 4th arm may have been locked as it was not in use before the events.The instrument was free of any tissue, but was bent at an angle preventing the removal through the trocar.The use of the immediate release key (irk) was utilized but unsuccessful as the jaws were not holding onto anything.Eventually, the bedside assist pulled harder on the instrument and removed the instrument and trocar together.There was no injury to the patient at the port site due to the removal.The procedure was then converted to laparoscopic, the surgeon re-inserted the da vinci trocars and used the same port sites to complete the procedure which involved suturing the hiatus.The patient was hospitalized that night and a cardiac workup was completed.The results were within normal limits, there were no indications as to what caused the event intraoperatively.The patient was discharged home the following day.There have been no reports of usm4 issues on that system since the event, the surgeon has continued to use the system with no complications.

Manufacturer Narrative

Intuitive surgical inc.(isi) received the tip-up fenestrated grasper instrument associated with this complaint.Failure analysis did not confirm nor replicate the reported event.The instrument passed the recognition and engagement tests, moved intuitively with full range of motion in all directions.The instrument was fully functional.No product issue was identified.

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: 18375700
• MDR Text Key: 331129205
• Report Number: 2955842-2023-21472
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-46
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2019
• 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