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

Model Number 380614-06

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 11/15/2021

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.Fse replaced the endoscopic camera manipulator (ecm) to resolve the issue.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) has not yet received the replaced ecm component for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product or this event.No image or video was provided for review.Technical support engineer (tse) reviewed the system logs at the time of the call into technical support.The logs confirmed the reported errors.This complaint is being reported based on the following conclusion: 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.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 lymphadenectomy surgical procedure, the system displayed an error 23025.Technical support engineer (tse) reviewed the logs and confirmed the error 23025, pointing to endoscopic camera manipulator (ecm) axis 3 (insertion axis).Tse instructed the caller (nurse) to power cycle system several times with epo (emergency power off) and exercise the ecm axis 3.However, the error 23025 reoccurred after every power cycle with epo.Tse informed the caller if the camera is not installed on the ecm, the surgeon would not be able to move the instruments.The procedure was converted to open surgery.There was no report of injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and on 19-nov-2021, and obtained the following additional information: it was reported that the da vinci system was used in the previous surgery, than in the second surgery an error message came directly from the camera arm.The technical assistance was called immediately when the problem occurred; however, the issue could not be fixed.The site confirmed that the da vinci surgery had to be converted to an open surgery.Since the da vinci camera arm could not be used, the system was not operational.The open surgery was completed without any further issues.The patient's current health status and patient demographics cannot be released.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, h3, h6 and h10.D02-intuitive surgical, inc.(isi) has received the endoscopic camera manipulator (ecm) associated with this complaint and completed investigations.Failure analysis investigations was able to reproduce the reported error 23025 during power up.To correct the problem, the axis 3 motor will be replaced.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• 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: 12955476
• MDR Text Key: 288358197
• Report Number: 2955842-2021-11687
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380614-06
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2010
• 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: Female