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

Model Number 381121-24

Device Problem Loss of Power (1475)

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

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the customer converted the procedure to open surgery due to powering down of the patient side cart (psc).However, through troubleshooting, it was determined that the psc circuit breaker was set to the off position, and this caused the psc to run in battery mode and eventually to lose power.The intuitive surgical, inc.(isi) technical support engineer (tse) instructed the customer to set the psc circuit breaker to the on position to correct the issue.The system was working properly, and no additional action was required.

Event Description

It was reported that during a da vinci-assisted surgical procedure, that the system was running in battery mode.Caller took no action.Shortly after starting the procedure, the patient side cart (psc) powered down.The customer managed to remove the instruments from the patient and the procedure was converted to open surgery.The customer called intuitive surgical, inc.(isi) technical support engineer (tse) after the customer already converted the procedure.According to the customer, this surgery had a high risk to be converted to an open surgery right from the beginning.During troubleshooting, it turned out that the circuit breaker from the psc had been set to the off position.After correcting that issue, the psc was working.Its battery was charging.The procedure was converted to open surgery with no patient harm.Isi followed up with the initial reporter and obtained the following additional information: the tumor was quite large.The high risk of conversion was already known, and the patient was prepared for an open procedure from the very beginning.The patient tolerated the open procedure very well.The patient was not injured.Ports were placed at the time of the conversion to open surgery.During set up, the customer had identified that the system was running on battery power, but the cause could not be identified.The system was checked before use and immediately called the hotline.

• 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: 17906106
• MDR Text Key: 325301428
• Report Number: 2955842-2023-19067
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• UDI-Public: (01)00886874110898
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381121-24
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2017
• 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