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

Model Number 380652-41

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the operative complication cannot be determined.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.The surgeon believes the operative complication occurred during the specimen extraction which was done laparoscopically and was unrelated to the da vinci device or system.If additional information is received, a follow-up mdr will be submitted.No image or video clip for the reported event was submitted for review.A log review was conducted for the da vinci-assisted surgical procedure.The system appeared to be fine during this procedure.However, there were some errors related to the trumpf table.Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: vessel sealer instrument, sureform stapler, and the tip-up fenestrated grasper.The vessel sealer instrument and sureform stapler instrument are single-use instruments, and site reviews have shown that no complaints were filed against these instruments.This complaint is being reported due to the following conclusion: during a da vinci-assisted sigmoid colectomy surgical procedure, the patient¿s ureter was injured.After completing the colectomy, a stent was placed on the ureter to repair the injury.Although the surgeon believes the ureter could have avulsed during the laparoscopic specimen extraction with a laparoscopic grasper and not during the robotic portion or with a da vinci instrument, it is unclear how and when the ureter injury actually occurred.As a result of the intra-operative complication, the patient would undergo another procedure for the ureter repair and experienced additional hospitalization.The cause of the operative complication is unknown.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred.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.Field is blank because the product is not implantable.Information for the blank fields are not available fields are not applicable.

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the patient¿s ureter was injured.Intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following additional information regarding the reported event: the csr was present during the procedure and had a debrief with the surgeon on the day of the procedure and the next day.The surgeon monitored the ureter during mobilization and resection of the colon.A resident was supposed to remove the specimen; however, as the resident could not do it, the console surgeon scrubbed in and removed the specimen transanally as a laparoscopic procedure with a laparoscopic grasper.The surgeon identified an unintended avulsion of the left ureter during the specimen extraction.Then a da vinci-trained urologist was called in for assistance.The avulsed ureter was identified near the kidney, and then the ureter was clipped proximally and distally.After the ureter was identified and clipped, the anastomosis of the colon was completed robotically.After completing the colectomy, a stent was placed on the ureter to repair the injury.The surgeon had stated that logically the only time the ureter could have avulsed was during the laparoscopic specimen extraction with a laparoscopic grasper.He does not believe it would not have happened during the robotic portion of the procedure or with a da vinci instrument.The patient had an extended hospital stay and is reported to be recovering well.There was no video recording of the procedure, and none of the instruments will be returned to isi, as there was no malfunction of a da vinci system, instrument, or accessory.The csr stated that the patient would undergo another procedure for the ureter repair.

• 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: 14191103
• MDR Text Key: 294641722
• Report Number: 2955842-2022-11225
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/25/2022

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: 380652-41
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2019
• 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
• Patient Age: 54
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American