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

Model Number 380652-46

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/02/2022

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.The fse was able to replicate the issue and confirmed the port clutch button did not work.The fse found multiple instances of the port clutch button issues in the system logs.The fse replaced the universal surgical manipulator (usm) to resolve the issue.The system was tested and verified as ready for use.Isi has received the usm involved with this complaint; however, the evaluation is not completed yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.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 system was not connected to the network at the time of the event.An event verification confirmed the procedure was performed on the reported event date (b)(6) 2022 on system sk2909.This complaint is considered a reportable malfunction event due to the following conclusion: a usm was disabled after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.While there was no harm or injury to the patient, system unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a procedure change.

Event Description

It was reported that during a da vinci-assisted surgical procedure, an arm 2 did not work while docking.The customer was not able to move the arm.In additional to this, the trocar made a sound after being connected to the arm.The customer described the sound as a low hum which eventually stopped.The customer stated that they undocked the arm and tried another and heard the sound again.The technical service engineer (tse) explained that the sound may have been the patient side cart (psc) stabilization feet deploying.The customer undocked the arm 2 and used another arm in its place.The procedure was completed with no reported patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 07-june-2022: the customer explained that when the trocar was placed on arm 2, the system made a noise and jolted.The customer undocked arm 2 and tried attaching the trocar on another arm.The customer still heard the sound, but the system did not jolt.Arm 2 was disabled.The issue occurred during procedure and ports were placed at the time.The customer stated there were no errors at the time of the issue.Arm 2 was not used for the remainder of the procedure.The procedure was completed robotically with no injury to the patient.The customer stated they only needed three arms for the case.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the universal surgical manipulator (usm) involved with this complaint and completed the device evaluation.The usm was returned for failure analysis, but the reported failure of the clutch button not working and couldn't move the arm was not replicated.However, error 25745 was confirmed via error logs in multiple instances.The unit was tested on an in-house system and failed normal mode.The unit was passed lissajous, sensor check, sine cycle, carriage sine cycle and direction test.The top clutch switch, axes controller spar button board1 and flat flex cable (ffc) will be replaced as a fix.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 14898700
• MDR Text Key: 303309476
• Report Number: 2955842-2022-12760
• 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,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-46
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White