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

Model Number 380652

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/21/2024

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 whipple procedure, a vessel bled after a clip was applied with a medium-large clip applier instrument.The inferior pancreaticoduodenal artery (ipda) was ligated with a 2-0 silk tie and a clip using a medium-large clip applier instrument was placed on the stay side, and the vessel sealer extend (vse) instrument was used on the specimen side.As dissection continued, brisk bleeding was observed from the ipda.An initial attempt at suturing was attempted robotically but was unsuccessful.Therefore, the bleeding was controlled with arm 1.In a controlled fashion, arms 2-4 were undocked and the operation was converted to open laparotomy.The instrument release key (irk) was then used once the conversion was successful to control the bleeding by hand.The operation was completed after the specimen was removed to gain better visualization and the bleeding was controlled with a prolene suture.Approximately one liter of estimated blood loss occurred, no blood products were given.On video review later, the surgeon noticed that the arm 3 which held the vse instrument had rubbed up multiple times along the clip during further uncinate dissection, causing the clip to fall off and likely leading to the bleeding.The patient is recovering well.

• 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: 19128659
• MDR Text Key: 340445795
• Report Number: 2955842-2024-13284
• Device Sequence Number: 1
• Product Code: NAY
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652
• 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: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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