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

Model Number 380677-24

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/01/2022

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 replaced the surgeon side console (ssc) foot pedal, which resolved the issue.The system was tested and verified as ready for use.Isi received the part involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the reported issue.Fa observed that the top cover of the camera pedal was falling off.Both the yellow and blue pedals made noise when depressed.A review of the site's complaint history does not reveal any related complaints involving this product and/or this event.No image or procedure video was provided for review this complaint is considered a reportable event due to the following conclusion: the customer moved to the second surgeon side console (ssc) after the start of the procedure due to the camera pedal falling off.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 pancreaticoduodenectomy surgical procedure, the site was experiencing an issue with the robot camera pedal falling off of the surgeon side console (ssc).The caller stated that the surgeon moved to the second ssc to complete the procedure.The caller stated that they were continuing with the case.The technical support engineer (tse) viewed the live logs and noted no associated errors.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed-up with the customer and obtained the following information: the initial reporter confirmed that the procedure was completed with the second ssc without any injury or harm to the patient.

• 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: 13967215
• MDR Text Key: 297334206
• Report Number: 2955842-2022-10830
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-24
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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