MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE, RECERTIFIED

Model Number	380689-03
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the medical grade power supply (mgps), generic power distributor (gpd), and the surgeon back plane (sbp).The system was tested and verified as ready for use.Isi has requested the mgps, gpd and sbp involved with this complaint be returned but the products have not been received yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.A review of the site's system logs for the reported procedure date was conducted by technical support when the customer called for troubleshooting assistance and found the communication errors between the ssc and vsc related to the reported complaint.This complaint is being reported as a reportable malfunction event due to the following conclusion: the customer converted to a laparoscopic procedure after the start of the procedure due to non-recoverable errors.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.
Event or Problem Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the system had non a recoverable error 17.The customer had power cycled the system.The technical support engineer (tse) checked the system logs and found a communication issue between the surgeon side console (ssc) and the vision side cart (vsc).The tse advised the customer to hard power cycle the system and reseat the blue fiber cable to both ends, but the issue still persisted.The procedure was converted to laparoscopy with no reported injury.An intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 10-may-2022: the procedure was converted to laparoscopy due to non recoverable error 17.The system functionality was checked upon powering on the system and the system was booted up properly.The isi field service engineer (fse) replaced the parts to resolve the issue.
Additional Manufacturer Narrative
Evaluation information can be found in the following fields: intuitive surgical, inc.(isi) received the medical grade power supply (mgps) involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations could not reproduce nor confirm the customer reported complaint.In house fa installed and tested the mgps on the pca test system.The system started without any errors.Then 10 power cycles were performed on the mgps and the system works normally without errors, however the unit is dirty and needs to be updated.Intuitive surgical, inc.(isi) received the generic power distributor (gpd) involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations could not be reproduce the customer reported complaint.However, the error/fault was confirmed via error logs/ system logs.In-house fa installed on the pca test system and was powered on showing no errors.The fa verified the power switches and emergency power off (epo) buttons worked.The voltage and current status was normal.Fa conducted 10 power cycles on gpd and found no issues.The system was idle for 20 minutes.The error logs for the power supply showed error 31030, which meant "system_err_subsystem_startup_failed ".This concluded that the power supply has an timeout/intermittent issue.Intuitive surgical, inc.(isi) received the surgeon back plane (sbp) involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations confirmed the customer reported complaint.Fa performed visual inspection, there's evidence of fluid running down the board.The problem was fluid intrusion.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: SURGEON SIDE CONSOLE, RECERTIFIED
• 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: 14598914
• Report Number: 2955842-2022-12027
• Device Sequence Number: 12283310
• Product Code: NAY
• UDI-Device Identifier: 00886874110782
• UDI-Public: (01)00886874110782
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: 380689-03
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian