MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC WECK VISTA; BLADELESS OBTURATOR

Model Number 470359

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Great Vessel Perforation (2152)

Event Date 10/23/2023

Event Type  Death  

Manufacturer Narrative

Because ports were not placed and the da vinci system was never docked, there are no system logs available for review.A review of the event was performed by an intuitive surgical, inc.(isi) medical safety officer (mso) who concluded that the patient in this report died as a result of an injury which occurred at the beginning of the procedure during port placement.According to the information provided, the patient had a high bmi.Access attempts were unsuccessful using the standard intuitive surgical 100 mm port, a longer 150 mm port was then used to attempt access, but hemodynamic changes were noted.The surgeons converted to an open procedure and a vena cava injury was discovered.Despite resuscitative efforts, the patient did not survive.Based on the information provided in the summary of events, insufficient information exists to ascertain if any intuitive surgical products contributed to this event.The ifu for the da vinci xi systems contains the following cautions to minimize the risks associated with port placement: caution: to minimize the risks associated with port placement ensure the following to prevent tissue injury: appropriate patient positioning to shift organs away from the port placement site.An adequate level of insufflation.Obturator tip is pointing away from major vessels, organs, and other anatomic structures.When possible, visualization of the entire insertion of the cannula using the endoscope is preferred.Utilize continuous, controlled pressure with a deliberate rotating motion when placing the cannula and obturator.

Event Description

It was reported that during initial port placement for a da vinci assisted hysterectomy, the patient expired.Intra-abdominal access was attempted but was unsuccessful due to the patient's bmi of 44 and subsequent thick abdominal wall.After placing the standard-length trocar, the surgeon upsized to the long length trocar, and went back through the layers where a little bit of muscle was seen.The obturator was taken out, the scope was placed in the cannula and a small amount of blood was seen in the bottom of the cannula, but otherwise, they could not see anything.When the surgeon removed the cannula, clotted blood was noted on the edge.After the cannula was removed, the patient became tachycardic, then bradycardic and a code was initiated.A general surgeon assisted with conversion to open surgery and it was discovered that the vena cava was injured during trocar placement.The vena cava bleeding was controlled with pressure, but the patient expired prior to a repair being made.The estimated blood loss was 2l.Even after upsizing it was never clear if intraabdominal access was achieved and the insufflation was never turned on.An autopsy is scheduled; however, hospital administration informed that they would not be sharing any further information, including the autopsy results.

• Brand Name: WECK VISTA
• Type of Device: BLADELESS OBTURATOR
• 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: 18157212
• MDR Text Key: 328349908
• Report Number: 2955842-2023-20251
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152663
• 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
• Report Date: 10/23/2023

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: 470359
• Device Catalogue Number: 470359
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Female