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

Model Number	380689-02
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting repeated recoverable fault 23017, an investigation is in progress to determine the cause of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue.An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the mtm to resolve the reported issue.Isi has not yet received the da vinci product to perform failure analysis.Therefore, the root cause of the alleged customer reported failure mode has not been determined.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 no errors related to the reported complaint.The investigation to determine the cause of this reported event is currently in progress.As such, the probable root cause cannot yet be determined based on the information provided.This complaint is considered a reportable malfunction event due to the following conclusion: it was alleged that the system had recoverable faults 23017 and the fse replaced the manipulator to resolve the issue.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 procedure change.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the system had repeated recoverable fault 23017.The customer was recovering error each time.The system was not connected to onsite.The procedure was completed with no reported injury.An intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the issue occurred during procedure.The system functionality was checked upon powering on the system and the system initially powered on without errors.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the master tool manipulator (mtm 2) involved with this complaint and completed the device evaluation.Failure analysis investigation was able to reproduce the customer reported issue during sine cycle.During evaluation, error 23017 was observed along axis 5, causing the mtm2 to fail during sine cycle.
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: 16170355
• Report Number: 2955842-2023-10101
• Device Sequence Number: 20459243
• 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,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 380689-02
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 01/15/2023
• Supplement Report FDA Received Date: 05/12/2023
• 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