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

Model Number 380652-37

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 10/19/2021

Event Type  Death  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.Therefore, no product is expected to be returned to isi for failure analysis evaluation.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No images or videos were obtained of this reported event.A medical review was performed by an isi medical safety officer and the following information was provided: "based upon the information provided in the description of events above, i am not able to reasonably determine if the da vinci system, instrumentation, and/or accessories caused or contributed to the pulmonary artery injury that caused the patient¿s acute blood loss anemia, hypoperfusion, and mortality during a da vinci assisted paraesophageal hernia repair." a review of the system logs for the procedure date of (b)(6) 2021 has been performed and the following was observed: no relevant errors were observed during this procedure.Additionally, the 30 degree endoscope and small clip applier were reused in subsequent procedures.The vessel sealer extend is a single use instrument and therefore was not used in subsequent procedure.The other instruments used during this procedure have not been reused in subsequent procedures: cadiere forceps (part number (pn): 471049-08 / lot number (ln): n12210719-0381 / 4 uses remaining), tip-up fenestrated grasper (2 uses remaining), mega suturecut needle driver (11 uses remaining), cadiere forceps (pn: 471049-08 / ln: n11210726-0096 / 14 uses remaining).A site history shows that none of the instruments used during this procedure have any complaints made against them.This event is being reported due to the following conclusion: it was reported that during a da vinci-assisted lobectomy, the pulmonary artery was damaged causing the patient to hemorrhage.The procedure was converted to open and the patient ultimately expired due to blood loss.There is no allegation that a malfunction of a da vinci product occurred.

Event Description

It was reported that during a da vinci-assisted lobectomy procedure that the surgeon hit the pulmonary artery and the patient expired.On 22-oct-2021, the site intuitive surgical inc.(isi) clinical sales representative (csr) was contacted and additional information was obtained about the complaint: the csr had not been in contact with the surgeon of this case yet.The csr reported that the surgeon was dissecting around the artery when it was hit and started bleeding.The surgeon attempted a convert to open but the patient expired before they could convert in time.The site reported that there were no malfunctions of a da vinci product during this procedure.The surgeon reported that the anatomy was difficult.On 08-nov-2021 isi contacted the surgeon of this procedure and additional information was obtained about the complaint: the surgeon reported that they had control of the bleeding with the da vinci robot and converted to open.After converting, the or staff undocked the da vinci and started to control the bleed via open, then lost control of the bleed.On 09-nov-2021, isi contacted the surgeon of this procedure and additional information was obtained about the complaint: the surgeon said that he does not think that a da vinci system, instrument, or accessory contributed to this event but that the da vinci products are related as they were being used for this procedure.The surgeon reported using an ¿extended bipolar grasper¿ while taking down a cancerous lymph node on the trunk of the pulmonary artery on the anterior branch of the right upper lobe.The surgeon was working on the backside of the vessel when the vessel was damaged and began to bleed.The surgeon reported that vision was difficult due to working on the backside of the vessel.The surgeon clamped down on the bleed to control it while they converted the procedure to open.After the conversion, the surgeon said he tried to stop the bleeding with his hand and that multiple blood transfusions were administered.The surgeon reported that the patient ultimately expired due to blood loss.

Manufacturer Narrative

The system logs were reviewed by intuitive surgical, inc.(isi) technical support on 28-apr-2022.It was noted that errors 31010 and 100 occurred on the system on the date of the procedure, on (b)(6) 2021.Error 31010 - this was reported by sterile adaptor.Usually related to the sterile adaptor.Error 100 ¿ setup join (suj) moved without being clutched on arm 1.The long bipolar grasper, referred to as the ¿extended bipolar grasper¿ by the surgeon, was used in subsequent procedures on (b)(6) 2021 until all uses were expended with no reported complaints.All other reusable instrumentation installed during the reported procedure were used in subsequent procedures with no reported complaints.The vessel sealer extend instrument, sureform 45 stapler instrument, and reloads are all single-procedure devices.

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: 12848638
• MDR Text Key: 281067064
• Report Number: 2955842-2021-11547
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-37
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2016
• 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 Sex: Male