MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number 380677-03

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted rectopexy surgical procedure, the clinical sales representative (csr) called an intuitive surgical inc.(isi) technical support engineer (tse) to report that the finger clutch button was sticking.The surgeon moved to the second surgeon side console (ssc) and continued with the case.The customer requested that the sticky finger clutch button be replaced.The procedure was completed as planned with no reported injury.Isi made multiple follow-up attempts 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.The fse replaced the master tool manipulator (mtm).The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) received the master tool manipulator (mtm) involved with this complaint and completed the evaluation.Failure analysis reproduced the reported complaint.The opto button assemblies were replaced as a fix.A log review was performed and the following was confirmed: the rectopexy was performed on (b)(6)2022 on system sk0231.This complaint is considered a reportable event due to the following conclusion: the surgeon was unable to use the surgeon side console (ssc) after the start of the procedure due to the finger clutch button sticking.The surgeon was able to move to the second ssc to complete the procedure.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 procedure change.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE, SMART PEDALS
• 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: 15222701
• MDR Text Key: 304621649
• Report Number: 2955842-2022-13446
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 0886874110744
• UDI-Public: (01)0886874110744
• 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: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-03
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES