MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-38

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

Patient Problem Bowel Burn (1756)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the intra-operative complication is unknown.If additional information is received, a follow-up mdr will be submitted.An isi field service engineer (fse) investigation was completed.The fse completed verification of the erbe generator.There were no errors on the erbe and electrical safety was completed on the erbe and the vision side cart (vsc) with passing results.The system was tested and ready for use.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.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted sleeve gastrectomy surgical procedure, the patient's bowel was burned.The surgeon reported that he was using a third-party cautery pen and an unspecified laparoscopic cautery instrument when energy was discharged inside the abdomen.At this time, the cause and severity of the bowel injury is unknown.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Information for the blank fields in name and address is not available.Pma/510(k) number and adverse event are not applicable.

Event Description

It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the patient's bowel was burned with a cautery instrument.Intuitive surgical, inc.(isi) executive sales representative (esr) stated he was not present during the procedure; however, the surgeon had informed him that he was using a third-party cautery pen and an unspecified laparoscopic cautery instrument with the erbe generator when energy was discharged inside the abdomen and burned the bowel.The esr stated that the or manager later reported the issue was unrelated to an isi product.Isi made multiple follow-up attempts to obtain additional information from the surgeon.However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 13625774
• MDR Text Key: 286315751
• Report Number: 2955842-2022-10405
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 381121-38
• 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: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2020
• 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.