MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, RECERTIFIED

Model Number	380686-04
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting repeated recoverable faults on amr3, an investigation is in progress to determine the cause of this reported event.An isi field service engineer (fse) has been dispatched to investigate the reported event.The fse replaced the psm to resolve the repeated recoverable faults.The system was tested and verified as ready for use.The psm has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the unit is returned (post engineering evaluation) or if additional information is received.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: a psm was disabled after the start of the procedure and the surgeon was able to continue with the procedure robotically using 3 arms.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.System unavailability after start of a surgical procedure could lead to the procedure to be converted/aborted and may lead to an injury due to the patient's inability to tolerate a conversion/abortion.
Event or Problem Description
It was reported that during a da vinci assisted simple prostatectomy surgical procedure, the customer experienced repeated recoverable faults pointing to patient side manipulator (psm) / arm 3.The led indicator on arm 3 was blinking yellow, and when users tried to recover from fault, the error persisted.No error codes were noted so the customer made the decision to disable arm 3 and completed the procedure using the remaining three arms.The customer was not with the system during the call, additional troubleshooting was not possible.An isi technical support engineer (tse) checked the live logs and found several errors pointing at psm3.The procedure was completed with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.Followed up with the initial reporter and obtained the following additional information: the system was checked and powered on without errors.The procedure was successfully completed with 3-arms.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the patient side manipulator (psm) involved with this complaint and completed the product evaluation.Failure analysis investigation was unable to reproduce but could confirm the customer reported complaint as having occurred via field error logs.Visual inspection was performed.The psm was installed onto the system and powered up.The sine cycle and a test drive were performed without any issues.Tests performed via matlab passed.The psm2 was found to have no problem.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 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: 16526715
• Report Number: 2955842-2023-11237
• Device Sequence Number: 16799428
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 380686-04
• Device Catalogue Number: 380686
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/04/2023
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG