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

Model Number	380610-14
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
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.The fse replaced the left master tool manipulator (mtml) to resolve the issue.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) has requested the return the mtm involved in this complaint to perform failure analysis.At the time of this report, the product has not been received.
Event or Problem Description
It was reported that during a da vinci-assisted malignant hysterectomy surgical procedure, the system had a 23025 error.The customer stated that the left master tool manipulator (mtml) suddenly became unusable.The customer had already power cycled the system, and the error returned.Intuitive surgical, inc.(isi) technical support engineer (tse) asked the surgeon to exercise the mtml in every angle while the system was off.The tse warned the surgeon that the mtml fault could return at any time without prevention and that the mtml had to be replaced.The error returned after a new restart and no other surgeon side console (ssc) was available at the hospital site.The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following additional information: the surgeon confirmed that system functionality was checked upon powering on the system, and the system initially powered on without errors.The procedure could be continued laparoscopically with the robot.There was no problem for the patient apart from a secondary anemia on an uncollected parietal hematoma.
Additional Manufacturer Narrative
The master tool manipulator (mtm) was returned and triggered error 23025 during sine cycle testing.The axis 3 motor and motor cable will be replaced as a fix.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 20231229
• Report Number: 2955842-2024-19357
• Device Sequence Number: 8042362
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/21/2024

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: 380610-14
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2012
• 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: Female