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

Model Number	380690-03
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was unable to turn the lamp on, the fse replaced illuminator for the error, but that did not resolve the issue.The fse replaced the lamp module to resolve the issue, however multiple lamp modules were dead on arrival.The third lamp module worked, and the system was tested and verified as ready for use.Isi has not received the lamp module for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.Isi reviewed the site¿s complaint history and found patient identifier (b)(6) as a related complaint (the original complaint).
Event or Problem Description
It was reported that during a vinci-assisted hysterectomy surgical procedure, the customer received a recoverable fault 48245 during system check and identified the illuminator was not working.Intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr) and obtained the following additional information: the correct event date was 2nd december 2023.The issue happened before the start of the procedure.As soon as they switched on the illuminator to do the white balancing, it stopped working.The patient was induced, and the procedure was about to start.The procedure was converted and done laparoscopically.The conversion did not result in increasing port size incision or adding additional ports.The procedure got converted when they started to use the endoscope and it stopped functioning.The procedure name was robotic hysterectomy.The issue has been resolved and the lamp module has been replaced along with the illuminator.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the illuminator involved with this complaint to perform failure analysis.The illuminator was analyzed and found to confirmed the customer reported complaint.The component was installed into the test system and upon startup, the system immediately threw errors that indicated trouble communicating with the illuminator.Errors 48240 and 48238 where thrown, both pointing to trouble finding the illuminator.The complaint was confirmed based on failure analysis.The lamp module was returned and evaluated by the failure analysis team.Failure analysis investigation was able to replicate/confirm the customer-reported complaint.The lamp module was found to have a recognition failure.The lamp module was placed on an in-house system and did not appear in the tool table.The second lamp module was also returned and evaluated by the failure analysis team.Failure analysis investigation did not replicate nor confirm the customer-reported complaint.The lamp module was placed on an in-house system and was recognized.The lamp module light was turned on without issue.No product issue was identified.

• 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: 18406506
• Report Number: 2955842-2023-21693
• Device Sequence Number: 18366992
• Product Code: NAY
• UDI-Device Identifier: 00886874110799
• UDI-Public: (01)00886874110799
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2023

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: 380690-03
• 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: 12/02/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/23/2024
• 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 Age: 42 YR
• Patient Sex: Female