MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM, RECERTIFIED

Model Number	380690-03
Medical Device Problem Codes	No Device Output (1435); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
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 complaint.A review of the system logs confirmed the suspected illuminator.Functional testing reproduced the customer reported issue and investigation of the system found a defective illuminator.The fse replaced the illuminator to resolve the issue.The system was tested and verified as ready for use.Isi received the part involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed and replicated the reported complaint.Fa installed the illuminator in an in-house printed circuit assembly (pca) system and confirmed the reported issue.The illuminator was tested and displayed a recoverable error 297.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy procedure, the system displayed non-recoverable error 297.It was noted that the illuminator light emitting diode (led) indicator was not illuminated.The customer then received phone assistance from an intuitive surgical, inc.(isi) technical support engineer (tse).A review of the site's system logs confirmed the occurrence of the non-recoverable error 297 and recoverable error 48238.The customer was instructed to disconnect the communication cable between the illuminator and the dual camera ccu (doco) and perform a power-cycle.Once the system powered back on, the customer recovered from the error fault.Following this, an external laparoscopic illuminator was connected to continue the procedure.No further issue was observed.The procedure was completed as planned with no reported patient harm, injury, or adverse outcome.

• Brand Name: DAVINCI SI
• Common Device Name: VISION SIDE SYSTEM, 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: 16971837
• Report Number: 2955842-2023-14316
• Device Sequence Number: 6499614
• Product Code: NAY
• UDI-Device Identifier: 00886874110799
• UDI-Public: (01)00886874110799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2021

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: 380690-03
• Device Catalogue Number: 380690
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 05/22/2023
• 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: Male