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

Model Number 380677-10

Device Problem Failure to Sense (1559)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the mtm to resolve the issue.The system was tested and verified as ready for use.Isi has not received the mtm for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure caused the procedure to be converted to a laparoscopic procedure.This could potentially lead to an injury due to the patient¿s inability to tolerate a conversion.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.

Event Description

It was reported that during a da vinci-assisted surgical procedure, it was not possible to use the master tool manipulator (mtm).The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and found error 25520 pointing to faulty voltage in the mtm.The tse asked the site to power cycle the system; however, after startup the issue remained.The tse guided the surgeon to power down the system, exercise the mtm, and hard power cycle the surgeon side console (ssc); however, the issue remained.The procedure was converted to laparoscopic surgery with no reported injury.Isi followed up on 22-jun-2021 and obtained the following additional information: the system was inspected prior to use.There were no issues noted during set up of the system.The procedure was successfully completed laparoscopically.The issue occurred at the very beginning of the procedure.There were no post-operative complications.The patient demographics were not provided.

Manufacturer Narrative

D02: intuitive surgical, inc.(isi) received the master tool manipulator (mtm) involved with this complaint and completed the device evaluation.Failure analysis investigation reproduced the reported failure.Error 25520 occurred during sine cycle.The root cause was found to be due to a component failure.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI XI
• Type of Device: SURGEON SIDE CONSOLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 12142526
• MDR Text Key: 267897120
• Report Number: 2955842-2021-10772
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380677-10
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.