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

Model Number 380652-30

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

It was reported that during da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, the camera arm would have trouble going past the midpoint of the universal surgical manipulator (usm).The customer had to physically push it for it to go further in.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made a follow-up attempt to obtain additional information.However, no further details have been received as of the date of this report.

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 (usm) due to carriage being loose causing insertion issues at certain areas.The system was tested and verified as ready for use.The usm has been returned to intuitive surgical, inc.(isi) for evaluation.But evaluation is still not completed.If additional information is received, a follow-up mdr will be submitted.No image or video clip for the reported event was submitted to isi for review.Verification via logs confirms the occurrence of a radical prostatectomy with lymphadenectomy procedure on the reported event date of (b)(6) 2022 matching the documented event details.This complaint is considered a reportable event due to the following conclusion: an issue with the universal surgical manipulator (usm) was observed during the procedure.The procedure was completed with no reported injury.Fse investigation confirmed usm arm issue.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.System unavailability after start of a surgical procedure could lead to the procedure to be converted and may lead to an injury due to the patient's inability to tolerate a conversion.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the universal surgical manipulator (usm) involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The unit was tested on an in-house system and passed normal mode.In normal mode while back driving the unit and during the visual inspection, found resistance with the carriage loose on the insertion due to the nonconforming usm insertion linear rails.The unit went through testing on a psc fixture test platform (pftp) and passed direction tests, lissajous, cva characterization, sensors check, sine cycle, carriage friction test, brake release test, brake hold test, advanced brake test, carriage strength test, and carriage switches test.The usm insertion linear bearing rail will be replaced as a fix to the reported problem.Additionally, on (b)(6) 2022, additional information was obtained from robotics coordinator: there were no patient complications.The system did not throw a fault.The isi field service engineer (fse) arrived onsite and replaced the arm.The housing unit for the instrument had become dislodged from the track.

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: 15693661
• MDR Text Key: 306921412
• Report Number: 2955842-2022-14953
• Device Sequence Number: 1
• Product Code: NAY
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380652-30
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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