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

Model Number UNKNOWN

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

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

Event Date 02/22/2023

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.The trocar being placed was a da vinci 8mm cannula with a da vinci bladeless obturator, and visual assist using a stryker 5.0 endoscope.Trocars are the combination of an obturator within a cannula.They are used during laparoscopic and other minimally invasive surgery (mis) procedures to make small, puncture-like incisions in outer tissue layers.The obturator, in particular, extends past the tip of the cannula to assist in pushing through the patient tissue wall.Once placed, the obturator is removed and the cannula remains to allow surgeons to introduce surgical instruments.A review of the event conducted by an isi medical safety officer (mso) concluded that based on the information provided in the summary of events, this catastrophic injury occurred during initial port placement and before the intuitive surgical da vinci was docked.Aortic injuries are a well-known complication at the time of initial abdominal port placement regardless of the access technique and instrumentation used.Based on the information provided in the summary of events, insufficient information is available to ascertain if any intuitive surgical product directly contributed to this event.The user facility site history was reviewed, and no system or instrument log files were found; confirming the report that the da vinci system was never docked.This event is being reported due to the following conclusion: prior to a da vinci-assisted ovarian cystectomy procedure, during the initial trocar placement at the midline, the aorta was struck resulting in bleeding.The patient coded, was converted to open, and resuscitation efforts were provided; however the patient ultimately expired.The da vinci robotic surgical system was never docked.

Event Description

It was reported that prior to a da vinci-assisted ovarian cystectomy procedure, during the initial trocar placement at the midline, the aorta was struck resulting in bleeding.The patient coded and ultimately expired.The da vinci robotic surgical system was never docked.An intuitive surgical inc.(isi) clinical sales representative (csr) provided additional information about the event: the csr was not present when this event occurred, but arrived at the site as resuscitation intervention was being performed.The csr was outside of the operating room and spoke to multiple members of the or staff who informed the csr of the event.They reported that as the first assist placed the initial trocar of this procedure at the mid-line, the aorta was struck resulting in bleeding.The patient coded and resuscitation efforts continued for an hour.Open surgical access was completed, chest compressions were performed, and the site trauma team arrived to assist; however, the patient ultimately expired.It is unknown to the csr what other interventions were performed.It was reported that the trocar being placed was a da vinci 8mm cannula with a da vinci bladeless obturator, and visual assist using a stryker 5.0 endoscope.It was confirmed that the da vinci robotic surgical system was never docked.Attempts to obtain additional information from the surgeon and site risk management were made; however, no further details have been provided.

• 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: 16594992
• MDR Text Key: 311816535
• Report Number: 2955842-2023-11474
• 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: Physician Assistant
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• 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: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 37 YR
• Patient Sex: Female