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

Model Number 380652

Device Problem Insufficient Information (3190)

Patient Problems Failure to Anastomose (1028); Septic Shock (2068); Peritonitis (2252)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the postoperative complications cannot be determined.No products have been returned to intuitive surgical, inc.For evaluation.A review of the site's system logs for the reported procedure date could not be completed, as no onsite connection was available on the reported event date.

Event Description

Per information received from a patient of an alleged da vinci-assisted sigmoid and upper rectal resection procedure, the surgeon removed too little intestinal tissue when creating an anastomosis following the resection of an intestinal obstruction.The patient alleged that the tissue at the location of the anastomosis was necrotic.Following the procedure, the patient went into severe septic shock, and they were subsequently resuscitated.Several emergency operations followed, including a staged lavage, the creation of an artificial bowel outlet (hartmann's procedure) and, a year later, the repositioning of the artificial bowel outlet.The patient also underwent several hernia operations afterwards, as a result of this issue.The patient alleged that the surgeon required 8 hours to complete the procedure, rather than the standard 2 hours.They further alleged that the operation was knowingly unsuccessful when it was completed, yet nothing was done to correct the matter.On the contrary, instead of repairing the damage with an immediate follow-up operation, the patient was transferred to a normal ward overnight and was, therefore, not even in intensive care.The surgeon was unable to verify if the procedure was performed via a da vinci system or via a transenterix system, due to the extended length of time that has elapsed from the time of the surgery to now.At that time, in 2017, there was no onsite connection available; per the available documentation, the only da vinci-assisted procedures performed on the alleged event date were prostatectomies.The surgeon was unable to provide additional information regarding the event.

• 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: 18384286
• MDR Text Key: 331222560
• Report Number: 2955842-2023-21674
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/29/2023

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
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/22/2023
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 51 YR
• Patient Sex: Male