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

Model Number 380652-50

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

Patient Problem Adhesion(s) (1695)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the conversion of a portion of the procedure to open is due to patient anatomy.A follow-up mdr will be submitted if additional information is received.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Universal surgical manipulator (usm) 4 was replaced to resolve the error 32056 issue.The system was then tested and verified as ready for use.The usm was returned and evaluated by isi.The reported complaint (occurrence of error 32056) was confirmed, but not replicated during in-house testing.A review of the system logs confirmed that errors 32101, 32056, 48100 and 32058 were generated by the system and pointed to the axes controller motor (acm).However, the unit passed all tests when installed on a patient side cart (psc) fixture test platform and other test platforms.The acm printed circuit assembly (pca) was replaced as a precautionary measure.A review of the system and instrument logs has been performed.The logs showed error 32056 occurring.All reusable instruments used in the case were used in subsequent procedures with the exception of the fenestrated bipolar forceps and small grasping retractor and a site review shows no complaint filed against these instruments.No image or video clip for the reported event was submitted for review.The system logs were reviewed by an isi failure analysis engineer (fae) and the following findings were obtained: about an hour and a half after the start of the procedure, arm 4 experienced 32101 errors (which also led to some other errors including the 32056).The site tried recovering a few times, but the errors returned.Eventually the customer disabled the arm which allowed the error to be recovered but then restarted the system.When the system was turned back on, the arm was no longer disabled, causing the errors to return.The customer repeatedly disabled the arm and restarted the system.The third time the customer disabled the arm, they turned off the system and did not restart it.The customer experienced an issue with arm 4 which could not be recovered from.The customer elected not to continue using the system as a 3-arm system.This complaint is being reported due to the following conclusion: during a da vinci-assisted right hemicolectomy procedure, the surgeon decided to extend the surgical incision to perform an extra-corporeal anastomosis due to adhesions and small body habitus of the patient.

Event Description

It was reported that during a da vinci-assisted right hemicolectomy procedure, the surgeon elected to extend the incision line to perform an extra-corporal anastomosis due to the patient having extensive adhesions and small body stature.While in the process of undocking the system to perform extra-corporal anastomosis, arm 4 had a non-recoverable fault 32056.The site tried to recover the arm 4 fault but the error recurred.The site then tried to disable arm 4 by putting it in a stow position, but the error returned again.As the system was in a faulted mode, the surgeon was unable to go into following and control the instruments on the other arms.Since the instrument on arm 1 was grasping tissue, the instrument release key (irk) was used to open the jaws of the instrument to release tissue.The surgeon had already elected to perform the anastomosis extra-corporeally, prior to when the arm 4 issue occurred.The fault on arm 4 only occurred during the undocking process.The surgery was completed and there was no injury/harm to the patient.The procedure delay due to the fault and subsequent irk use was 5-10 minutes.The site called an intuitive surgical, inc.(isi) technical support engineer (tse) at the end of the procedure; however, the error 32056 issue associated with arm 4 was not resolved despite troubleshooting.The tse guided the site with disabling arm 4; therefore, the system could still remain usable as a 3 arm system.There were no reported post-operative complications and the patient was noted to be recovering well.There were no videos/images available for viewing.Demographic information/relevant investigation and relevant medical history were enquired but not provided.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following sections: g3, g6, h2, h3, h6, and h10.Corrected data can be found in section h6 (annex codes b, c, and d).Device evaluation information can be found in sections: h6 and h10.On 26-apr-2022, intuitive surgical, inc.(isi) received the following additional information from failure analysis of the fenestrated bipolar forceps which was released by the instrument release kit (irk): the fenestrated bipolar forceps associated with the reported event has been returned and evaluated by failure analysis.Failure analysis investigations did not confirm nor replicate the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.No damage found.The instrument was fully functional.

• 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: 13102398
• MDR Text Key: 285613797
• Report Number: 2955842-2021-11829
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2021
• 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.