MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, 4-ARM, RECERTIFIED

Model Number	380675-04
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting led off, an investigation is in progress 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.Isi did not receive a da vinci product involved with this complaint to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.This complaint is reportable malfunction event due to the following conclusion: the customer disabled usm 3 after the start of the procedure due to non recoverable error.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.Blank mdr fields: follow-up was attempted, but 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.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the system had patient side manipulator (psm) 3 led off, all other arms were working fine.An error 22003 reported in the system logs.The customer disabled the arm and recovered the error.Intuitive surgical, inc.(isi) technical support engineer (tse) suggested reboot the system and check.The tse suggested to try to recover the error, if not disable the arm and recover it, in this scenario only two arms is usable.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the system functionality was checked upon powering on the system and the system initially powered on without errors.The system had a single time non-recoverable fault 22003 and the customer disabled arm, without any attempt to recover the fault.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The customer hard power cycled the system after procedure and the issue was resolved.No site visit was conducted.The system was working properly and no additional action was required as the issue was resolved.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 4-ARM, 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: 16821514
• Report Number: 2955842-2023-12225
• Device Sequence Number: 6850166
• Product Code: NAY
• UDI-Device Identifier: 00886874110737
• UDI-Public: (01)00886874110737
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123463
• 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): 03/31/2023

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: 380675-04
• Device Catalogue Number: 380675
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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