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

Model Number	380690-03
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An isi field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse replaced the doco.The system was tested and verified as ready for use.Isi received the doco involved with this complaint and completed the device evaluation.Failure analysis investigation could not reproduce the reported failure.However, the error/fault was confirmed via error logs/system logs.The doco was installed onto a test system, where it ran ten power cycles and sat idle for one hour.The error 45311 was unable to be replicated.However, the error appeared on the logs.A review of the site's complaint history does not show any additional reportable complaints related to this product and/or this event.Based on the information provided at this time, this complaint is being reported due to the following conclusion: system unavailability after the start of a surgical procedure could lead the procedure to be converted and could lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that prior to starting (post-anesthesia) a da vinci-assisted surgical procedure, there was no left eye on the camera and error 45311 occurred.Prior to calling technical support, the nurse power cycled the system.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs and confirmed the loss of left eye vision due to error 45311.The tse guided the caller to shut down the system and reseat the camera cable.Then, the tse guided the caller to power cycle the endoscope controller (ec), dual controller (doco), vision side cart (vsc), and reseat the camera cables.After startup, the user recovered vision in both eyes.Post port placement, error 45311 reoccurred.The nurse replaced the camera and camera cable; however, the error did not resolve.The tse reviewed the live logs and saw errors 45311 and 45314 pointing to the camera video chain.The procedure was converted to laparoscopic surgery with no reported injury.Isi made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.

• Brand Name: DAVINCI
• Common Device Name: VISION SIDE SYSTEM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 11905540
• Report Number: 2955842-2021-10584
• Device Sequence Number: 14344042
• Product Code: NAY
• UDI-Device Identifier: 00886874110799
• UDI-Public: (01)00886874110799
• 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: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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