MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE, RECERTIFIED

Model Number	380689-03
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
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.The fse replaced the personality module surgeon console (pmsc).The system was tested and verified as ready for use.Isi has requested the pmsc involved with this complaint be returned but it has not been received yet.Therefore, the root cause of the alleged customer reported failure mode has not been determined.A follow-up mdr will be submitted upon completion of the failure analysis evaluation and if additional information is received.A review of the site's complaint history found no additional complaints related to this complaint.No image or video was available for review.A review of the site's system logs for the reported procedure date was conducted by technical support when the customer called for troubleshooting assistance.Investigation revealed repeated error 48100 and 40074 pointing to the system.This complaint is being reported as a reportable malfunction event due to the following conclusion system unavailability after the start of a surgical procedure (first port incision) lead to the procedure to be converted which may lead to an injury due to the patient¿s inability to tolerate a conversion.While there was no harm or injury to the patient reported, this failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the system had error 48100 on the personality module surgeon console (pmsc) and the personality module vision acquisition (pmva) nodes and the non recoverable error message 40074.The technical service engineer (tse) checked the logs and asked the customer to remove any video/audio cable from the pmsc.The customer reset the blue fiber optic cable connection and the customer confirmed issue remained same after resetting the blue fiber cable too.Tse asked to put the circuit breaker off on surgeon side console (ssc) side and do one more reboot without any success.The procedure was converted to laparoscopy with no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information on 20-nov-2021: the issue happened during the procedure after all ports were placed.It is unknown if the system was checked prior to use.All troubleshooting steps were exhausted with no resolution to the issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information can be found in the following fields: d11- intuitive surgical, inc.(isi) received the personality module surgeon console (pmsc) involved with this complaint and completed the evaluation.The customer reported issue was confirmed/ replicated.The reported problem was replicated by installing and testing this unit into the system.It failed with errors 40074 and 48250 "function call return error, initialize".The pmsc was contaminated and had corrosion.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: SURGEON SIDE CONSOLE, 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: 13006742
• Report Number: 2955842-2021-11743
• Device Sequence Number: 13926700
• Product Code: NAY
• UDI-Device Identifier: 00886874110782
• UDI-Public: (01)00886874110782
• 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,Followup
• Report Date (Section B): 11/19/2021

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: 380689-03
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 02/01/2022
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian