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

Model Number 380652-35

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2023

Event Type  Death  

Manufacturer Narrative

The hospital risk manager reported that they do not yet have any additional information available, and that there were no issues with an intuitive surgical product.A review of the site history logs for the instruments used during the probable reported procedure found that the following multiple use instruments have been used in subsequent procedures with no reported complaints: endoscope, monopolar curved scissors, prograsp forceps, mega needle driver.Two additional multiple use prograsp forceps with remaining lives have not yet been used again, and have no complaints reported.The vessel sealer extend that was used during the procedure is a single use device.Review of advanced energy logs show that the vessel sealer extend was installed and passed homing 3 times.There were 69 cut complete events with no errors.In addition, there was a cut failure, jammed blade and several open jaw angles due to blade exposure events recorded.A system log review did not reveal any system errors that would have caused or contributed to the reported event.A review of the logs for the 5 subsequent procedures performed with this system also did not show any errors that would cause or contribute to any related events.A device history record review for the device(s) used during the procedure showed no non-conformances were identified.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that based on the limited information provided in the summary of events, and the unknown circumstances around this patient¿s death, insufficient information exists to determine if any intuitive surgical instruments or products contributed to this event.

Event Description

As part of a litigation hold notice received from the site regarding a da vinci assisted hysterectomy, it was reported the patient expired.During follow-up, the hospital risk manager stated that they have not yet received the lawsuit, and therefore, they do not know what the plaintiff is alleging.At the site, there were no reports of issues with an intuitive surgical, inc.(isi) product or any human error associated with the procedure.The patient expired on the date of the procedure, while being transferred to the icu.

• 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: 18036146
• MDR Text Key: 326903639
• Report Number: 2955842-2023-19712
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• 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: 380652-35
• Device Catalogue Number: N/A
• 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: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2016
• 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: 52 YR
• Patient Sex: Female