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

Model Number	380686-04
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pyeloplasty surgical procedure, the customer contacted a technical support engineer (tse) and reported that arm 2 did not work anymore.The customer stated that the maryland bipolar forceps instrument was installed and the leds on patient side manipulator (psm) 2 were amber without an error code on the touchscreen.Prior to the call to technical support, the customer had replaced the instrument and reseated the sterile adapter (sa).The tse checked the logs and found 31010 and 282 errors indicating instrument sensor issues.The tse requested the customer to replace the drape on arm 2 without improvement.The psm 2 was not engaged with the sa.The tse guided the customer to check the pogo pins and psm wrist input cog, but no physical damage was found.The tse asked customer to perform a hard power cycle with an emergency power off (epo) but got the same result.The tse asked the surgeon if she could proceed with 3 arms, which was the case.The surgery was resumed.The customer would postpone the surgery of this afternoon, but the customer needed their field service engineer (fse) to resolve the issue as soon as possible due to another procedure scheduled for the next day.A field service order (fso) was dispatched.The procedure was completed as planned with no reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.No site visit was conducted as customer declined system repair.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, RECERTIFIED
• 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: 20726318
• Report Number: 2955842-2024-21909
• Device Sequence Number: 18373423
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• 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
• Report Date (Section B): 10/22/2024

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: 380686-04
• Device Catalogue Number: N/A
• 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: 10/22/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Prefer Not To Disclose