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	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical extraperitoneal without lymphadenectomy prostatectomy surgical procedure, the customer informed the intuitive surgical, inc.(isi) technical support engineer (tse) that message "insertion axis not free to move" appeared on patient side manipulator (psm) 1.The customer power cycled the system, but the message persisted.The customer stated that there was no obstacle preventing the movement of the insertion.The tse had the customer move the insertion axis to the top manually and then perform a hard power cycle, which cleared the message.However, the instrument could not be inserted into psm 1.The tse explained that the insertion axis could have physical damage, and psm 1 could not be used in the procedure.The surgeon elected to continue the procedure with three psms.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the system was powered on without error.The customer disabled psm 1 during the procedure.The procedure was completed robotically with the remaining three psms.
Additional Manufacturer Narrative
Based on the claim against the product, an investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse confirmed the reported issue.The fse replaced psm 1 to resolve the issue.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis.The psm was analyzed and found to have non-intuitive motion during since cycle.Axis 3 brake will be replaced as a fix.A root cause of the reported failure was attributed to a component failure.The complaint regarding the psm issue was confirmed based on the field evaluation and failure analysis, which indicates that the device did contribute to the customer reported issue.No image or video clip for the reported event was available for review.Procedure logs confirmed a radical extraperitoneal without lymphadenectomy prostatectomy procedure took place on (b)(6) 2022 via system (b)(4).This complaint is being reported due to the following conclusion: the customer abandoned a patient side manipulator after the start of the procedure due error message.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/abortion.

• 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: 15998583
• Report Number: 2955842-2022-15956
• Device Sequence Number: 6656327
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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: 380686-04
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/16/2022
• 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: Male