MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; VISION SIDE SYSTEM, RECONDITIONED

Model Number 380721-01

Device Problems Loss of Power (1475); Failure to Power Up (1476)

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

Event Date 08/05/2020

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.The reported complaint was confirmed based on the field evaluation.The fse replaced the core power tray assembly, and the vision side cart (vsc) powered on successfully.The system was tested and verified as ready for use.Isi has not received the core power tray assembly for failure analysis investigation.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.A review of the system log confirms there was no procedure performed with system (b)(4) on (b)(6) 2020.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: a da vinci system malfunction occurred, rendering the da vinci system unavailable for use after the start of a surgical procedure.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 total benign hysterectomy surgical procedure, the customer called in to report that the vision side cart (vsc) stopped working and had no power.The customer stated that initially, the vsc had power, and the site had placed ports and then docked.After the patient was docked, the vsc lost power.The customer had attempted to troubleshoot prior to calling in for technical support with no success.The technical support engineer (tse) asked if the instruments were installed, and the customer stated that they had undocked the patient side cart (psc) from the patient (patient was under anesthesia).The customer confirmed that the vsc power light emitting diode (led) was not lit, and the surgeon side console (ssc) was not connected to the vsc.The tse noted that the system was not online at the time of the call, so logs could not be reviewed.The tse had the customer cycle the vsc circuit breaker and then relocate the vsc power cord to a known good wall outlet, but the issue persisted.The customer also confirmed the vsc circuit breaker was on.The tse had the customer power off all components (ssc, vsc and psc), turn off the circuit breakers, and cycle the vsc core circuit breaker.The customer turned back on all circuit breakers and stated that they could hear the fan from the vsc, but the power led did not light up.The tse had the customer attempt to power on from the vsc power button but no change.The customer then stated that she was unsure of how the surgeon would proceed with the case.There was no report of patient harm, injury or adverse outcome.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the procedure was aborted.System functionality was checked upon powering on the system and no issues were noted.The issue occurred at the beginning of the procedure right after the patient was docked.It was confirmed there was no patient harm.The customer was not able to provide information about the patient's medical history/tests nor the patient demographic information.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following fields: d9, g3, g6, h2, and h3.Product evaluation information can be found in the following fields: h6 and h10.D02 intuitive surgical, inc.(isi) received the core power tray assembly involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the reported failure.The core power tray assembly was installed on a printed circuit assembly (pca) test system, and it could not power on the core.The output voltage was measured for both power supplies, and power supply 1 output had 0 v.Power supply 2 was fully functional.Power supply 1 would be replaced.

• Brand Name: DA VINCI XI
• Type of Device: VISION SIDE SYSTEM, RECONDITIONED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10470112
• MDR Text Key: 242208718
• Report Number: 2955842-2020-10837
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• 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,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 380721-01
• Device Catalogue Number: 380721
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2018
• 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