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

Model Number	380610-13
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
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 event.Fse confirmed the issue and replaced the dual motor drive (dmd) board, surgeon back plane (sbp) and generic power distributor (gpd) printed circuit assembly (pca) boards to resolve the issue.The system was tested and verified as ready for use.Isi received the replaced dmd for investigation.Dmd board was installed into a test system and passed all testing specification.Isi received the replaced sbp for investigation.The circuit board had aged and was burnt out.The printed circuit board (pcb) had oxidized, and components were burned.Isi received the replaced gpd pca boards; however, failure analysis has not completed their investigation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted when failure analysis has completed their investigation.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy (radical salvage) surgical procedure, the nurse contacted dvstat to report an issue.The caller stated that the system reported error code 857.The technical support engineer (tse) guided the site to hard power cycle the system twice and to press the ergonomic switch several times but the issue remained.The procedure was converted to traditional laparoscopic surgery with no reported injury.Isi obtained the following information based on a follow-up: the patient tolerated the change when the procedure was converted.The system was inspected prior to use.No issues were noted during the set up of the system.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the replaced generic power distributor (gpd) printed circuit assembly (pca) boards but the reported failure could not be reproduced.The pca tech was unable to reproduce the failure report by installing this board into a pca test system.The surgeon console booted up normally, ran sine cycle, 20 power cycles, and sat idle for 1 hour without any errors.

• Brand Name: DAVINCI SI
• Common Device Name: SURGEON SIDE CONSOLE
• 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: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20186786
• Report Number: 2955842-2024-19188
• Device Sequence Number: 12824489
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: 380610-13
• Device Catalogue Number: 380610
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2011
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG