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

Model Number	380686-04
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was confirmed based on the field evaluation.The power supply was replaced to resolve the reported event.The system was tested and verified as ready for use.Isi received the power supply involved with this complaint and completed the device evaluation.Failure analysis could not reproduce the reported event, but the event was confirmed via logs.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the patient side cart (psc) turned to battery mode.The field service engineer (fse) was at the site for a case observation and had performed a hard power cycle to make the system ready for use.An intuitive surgical, inc.(isi) technical support engineer (tse) was contacted and reviewed the error and found 817.The tse stated the auxillary power board (apb) or medical grade power supply (mgps) may have malfunctioned during the time of event.The procedure was converted to open surgery.Isi followed up with the initial reporter and obtained the following additional information: the issue was identified during the procedure.The psc switched to battery mode and unable to bring to normal mode.No troubleshooting was performed with dvstat.There were no issues noted during set up of the system and the system was inspected prior to use.There were no issues with the port placement(s) and the surgical staff did not observe that there were any outside influences that were impeding movement of the system / patient side manipulators (psm).Troubleshooting steps were performed with the fse but technical support was not involved.

• 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: 17046173
• Report Number: 2955842-2023-15551
• Device Sequence Number: 14743524
• Product Code: NAY
• UDI-Device Identifier: 00886874110775
• UDI-Public: (01)00886874110775
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 380686-04
• Device Catalogue Number: 380686
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/02/2023
• 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: Unknown