MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number 381121-29

Device Problems Visual Prompts will not Clear (2281); Output Problem (3005)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted hysterectomy-malignant surgical procedure, monopolar and bipolar energy were not working.The customer attempted to replace energy cables, and instruments with no success.The customer used a third-party generator (force triad) and continued with the procedure.Intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and noted u-04 error on the integrated electro surgical unit (iesu).Tse informed the customer to reboot the iesu.Isi followed up with the initial reporter (nurse) and obtained additional information: the procedure was completed robotically using the third-party generator with no injury to the patient.

Manufacturer Narrative

Intuitive surgical, inc.(isi) field service engineer (fse) followed up with the customer on the phone.The customer power cycled the system and the integrated electro surgical unit (iesu) to clear the errors.The system and iesu powered back on without any errors.No site visit was conducted.The system was working properly and no additional action was required.A review of the site's system logs for the reported procedure date was conducted by intuitive surgical, inc.(isi) technical support engineer (tse).Investigation revealed the following possible related system errors: u-02 on the integrated electro surgical unit (iesu).No image or video clip for the reported event was submitted for review.This complaint is considered a reportable event due to the following conclusion: the customer elected to use the third-party generator after the start of the procedure due to errors on the integrated electro surgical unit (iesu).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/abortion.

• Brand Name: DAVINCI XI
• Type of Device: VISION SIDE SYSTEM
• 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: 14069069
• MDR Text Key: 298805947
• Report Number: 2955842-2022-10991
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• 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: 03/10/2022

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: 381121-29
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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