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

Model Number	380690-03
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting the vessel sealer was not working, an investigation is in progress to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse replaced the instrument control box (icb).The system was tested and verified as ready for use.Isi has received the icb, however, failure analysis has not completed their investigation.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted when failure analysis has completed their investigation.The investigation to determine the cause of this reported event is currently in progress.As such, the probable root cause cannot yet be determined based on the information provided.This complaint is considered a reportable event due to the following conclusion: the customer converted to laparoscopy after the start of the procedure due to multiple vessel sealer instruments not working.While there was no harm or injury to the patient, system unavailability after the start of a surgical procedure could likely cause or contribute to an adverse event if it were to recur as it may lead to an injury due to the patient¿s inability to tolerate a conversion/abortion.
Event or Problem Description
It was reported that during a da vinci-assisted surgical esophagectomy transthoracic with chest anastomosis procedure, the customer was facing an issue with the vessel sealer.The customer stated that there was no effect when the pedal was pressed.The customer stated that they tried a second vessel sealer before calling into technical support without any success.The technical support engineer (tse) asked her to check the instrument control box (icb) module and it was on.The tse then asked the customer to reboot the generator, try the vessel sealer on another arm with no success.The tse confirmed with the customer that there was a sound when the pedal was pressed.The tse asked the customer to remove all instruments and restart the system and power cycle the vision side cart (vsc) breaker but there was no change.The tse asked the customer to disconnect the electric scalpel connected to the personality module energy device (pmed) at the back side of the vsc with no change.The tse asked customer to use a third vessel sealer but there was no change.The surgical staff decided to convert to laparoscopic surgery.They would like assistance from a field service engineer (fse).The procedure was converted to laparoscopy with no reported injury.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument control box (ibc) assembly involved with this complaint and completed the evaluation.Failure analysis (fa) investigation confirmed and replicated the customer reported complaint ¿vessel sealer not working¿.The printed circuit assembly (pca) technician was able to replicate the reported issue by visual inspection of the returned instrument control box (ibc) assembly and found the green connectors were damaged and the pin was bent.The damaged receptacle will be replaced as a fix to the reported problem.

• 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: 16725102
• Report Number: 2955842-2023-11904
• Device Sequence Number: 8116473
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/24/2023
• 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