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

Model Number 380652-44

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

Patient Problem Fistula (1862)

Event Date 11/29/2021

Event Type  Injury  

Event Description

It was reported that a needle was left in the patient during a da vinci-assisted sigmoid colectomy surgical procedure.As a result, the patient required an additional procedure for the needle removal.A precautionary diverting ileostomy was performed, secondary to a fistula from the attached needle to the colon.The intuitive surgical, inc.(isi) clinical sales representative (csr) obtained the following information from the surgeon.While the surgeon was performing an intracorporeal anastomosis, the surgeon left a v-loc stay suture next to the anastomosis.The executive medical team at the site had mandated the surgeon required a proctor due to complications from previous open surgery.The proctor who was present was a non-robotic surgeon.For an unspecified reason, he left the operating room while the anastomosis was being completed; however, the procedure was not completed.The surgeon was almost done with the procedure and started pulling out all the sutures.At that time, the surgical staff reportedly said the needle count was accurate.Based on that, when the surgeon cut the stay suture, she allegedly did not notice that the needle was attached to the colon.The surgeon then completed the procedure.It was confirmed there was no malfunction of an isi device or system to have occurred during the procedure.Post-operative day (pod) # 4 or 5, the patient had developed ileus.As a result, on pod #6, a ct scan was performed, and a needle was identified inside the patient.As a result, the patient underwent a second non-robotic procedure.The needle with the string was attached to the wall of the colon.The needle allegedly formed a fistula.After removing the needle with the suture, the surgeon performed a diverting ileostomy as a precaution.The patient is reported to be recovering well.In three months, the ileostomy will be reversed by another surgeon.There is no video recording or photographic images available for review.The csr stated that the personnel at the hospital are not allowed to share any information about the procedure.

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported incident is due to use error, and the needle that was left inside the patient is a non-isi product.If additional information is received, a follow-up mdr will be submitted.Site history review was conducted and found no additional complaints related to this event.A system log review cannot be performed because the system logs are not available at this time.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following: a surgical needle was left inside the patient during a da vinci-assisted procedure.An additional surgical procedure was required to remove the needle.The patient developed a fistula secondary to the needle attached to the colon.As a result, the surgeon performed a precautionary diverting ileostomy during the additional procedure.It was confirmed that there was no malfunction of an isi device or system.Although the needle retained inside the patient was a non-isi product, and the cause of the reported incident was due to use error, it is reported since it occurred during a davinci procedure.

• 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: 13142864
• MDR Text Key: 287200808
• Report Number: 2955842-2021-11853
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-44
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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 Sex: Male