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

Model Number 380614-07

Device Problems Device Displays Incorrect Message (2591); Intermittent Loss of Power (4016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/2020

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 upgraded the medical grade power supply (mgps) to the newer redundant power supply.After part replacement, the system seemed to be fine but after about 20 minutes, it switched over to battery again.The auxiliary power board (apb) board was replaced and system seemed to be operating normally initially and then, after 20 minutes switched to battery again.The old apb board was reinstalled, all connections for power was checked and the issue still reoccurred.Fse then checked the integrity of the power cord and found that when the cord was moved around, it intermittently switched the psc to normal power and then to battery.The power cord was replaced to resolve the issue.The upgraded mgps was left in the system.The system was tested and verified as ready for use.The unit was returned for failure analysis but the reported failure of ¿no battery message¿ could not be confirmed or replicated.The unit was installed into the test system and the patient side cart (psc) was powered up.The power supply passed current/voltage check and fan was running.The unit was left idle in normal mode for ten minutes and underwent ten power cycles without any issue or errors.There was no trouble found with the unit.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 video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted.Investigation revealed the following possible related system errors: error 817 which points to psc loss of ac power and switched to battery.The error occurred prior to following and was recovered by the customer.Multiple errors 816 (psc battery capacity detected as low) occurred as well after following before customer powered the system down.A system log review confirmed that a total hysterectomy procedure was carried out on system (b)(4) on (b)(6) 2020.Based on the information provided at this time, this complaint is being classified as a reportable event due to the following conclusion: the customer converted the procedure to another psc as the patient cart lost power and was running on battery in the beginning of the procedure, after following.Although no patient harm occurred, if this malfunction were to recur it could likely cause or contribute to an adverse event.

Event Description

It was reported that during a da vinci-assisted sacrocolpopexy hysterectomy surgical procedure, the customer received an error message stating "patient cart was intermittently switching over to battery".The intuitive surgical, inc.(isi) technical support engineer (tse) had the customer check the breaker, power cord and outlet power but there were no issues.The tse then had the customer power down and emergency power off (epo) the patient side cart (psc) but the issue persisted.The customer converted the procedure to another psc.There was no reported injury.Isi followed up with the reporter, who was present at the time of the incident, and obtained the following information: the issue occurred during the first case of the day.When she turned on the system in the morning, she noticed that the patient side cart (psc) battery level was yellow.The system was docked and the procedure was commenced.The system kept on giving recoverable errors and the staff would just recover the error each time.The surgeon was aware of the situation but decided to carry on the surgery as the system was still responding to his commands.According to the reporter, the surgeon was going to `get as far in the surgery as he could`as long as the system was still responding'.After about 10 minutes, the circulatory nurse decided to call isi technical support to troubleshoot the issue.They decided to convert the procedure to another psc as the error kept on recurring despite troubleshooting.The surgery was completed robotically and there was no injury to the patient.

Manufacturer Narrative

On 7/13/2021, intuitive surgical, inc.(isi) received the following additional information from failure analysis performed by the original equipment manufacturer (oem): the customer complaint was confirmed.The power supply unit had a mechanical noise coming from the fan.The fan was found to be dirty and was replaced.The unit was cleaned and passed all electrical tests.

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 95051
• MDR Report Key: 11165679
• MDR Text Key: 241371845
• Report Number: 2955842-2021-10033
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (y/n): N
• PMA/PMN Number: K081137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380614-07
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 07/13/2021
• 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
• Patient Age: 84 YR
• Patient Weight: 83