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

Model Number 380652-48

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2022

Event Type  malfunction  

Manufacturer Narrative

An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.Fse replaced the universal surgical manipulator (usm1).The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the usm involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation could not replicate the customer reported complaint.However, the error was confirmed along with error 23007 via error logs/system logs.An error 23007 shows that degree of freedom (dof 3) was causing the error.The usm was tested on an in-house system and passed normal mode.The usm was also tested on a psc fixture test platform (pftp) and passed lissajous, sensors check, sine cycle, but failed the low-speed friction on the yaw.The yaw and pitch motor modules, harmonic drives and the joint 3 bearings will be replaced as a fix.The yaw and pitch housing flat flex cable (ffcs) will also be replaced as a precaution.No image or video was available for review.A review of the site's system logs for the reported procedure date was not conducted by technical support when the customer called for troubleshooting assistance as the onsite connectivity was not available at the time of event.An event verification confirmed the procedure was performed on the reported event date on (b)(6) 2022 on system sk3862.This complaint is considered a reportable malfunction event due to the following conclusion: the customer converted to laparoscopy after the start of the procedure due to an inoperable psc.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the customer was unable to drive the patient side cart (psc).There were no error messages.An intuitive surgical, inc.(isi) technical support engineer (tse) asked the customer to perform a system reboot, but the issue remained.Then the customer tried to move the psc auto/manual drive lever to manual.However, the psc was still not able to be moved.The customer checked for any obstructions and no obstructions were found.Then the system received an error message that arm 1 was not free to move and to check for obstructions.The customer moved arm 1 around, but the issue persisted.The tse recommended the customer to perform a hard system reboot with the breaker, but that was not possible as the procedure had already begun and the camera was needed.The procedure was converted to laparoscopy with no reports of patient injury.Isi followed up with the initial reporter and obtained the following additional information on 18-august-2022: the procedure was converted to laparoscopy as the patient side cart (psc) was not able to be docked after port placement.The procedure was completed laparoscopically and there was no report of patient injury.

• 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: 15280380
• MDR Text Key: 305262183
• Report Number: 2955842-2022-13631
• 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,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-48
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2020
• 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