MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; VESSEL SEALER

Model Number	410322-05
Medical Device Problem Codes	Failure to Deliver Energy (1211); Visual Prompts will not Clear (2281); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted sleeve gastrectomy surgical procedure, the vessel sealer instrument would not seal, and the customer received an error message indicating that the software was out of date.It was reported that an audible signal (continuous tone) was heard while the pedal was pressed.The customer stated that no tissue effect was observed during the sealing cycle and there was no evidence of vessel calcification.According to the customer, there are no photographic images of the device(s) or a video recording of the procedure available for review.The customer could not get the vessel sealer instrument to work on the system.The customer stated that they checked the cable connections and found everything connected properly.The customer stated that they got a message stating the software may be outdated when installing the vessel sealer instrument.The technical support engineer (tse) reviewed logs and found 32005 faults on the system.The tse asked the customer if they tried a new vessel sealer instrument and the customer stated that they didn't.The procedure was converted to laparoscopic surgery with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: when the customer tried to fire the vessel sealer instrument, the customer received an error message indicating that the software was out of date across the screen and the instrument would not do anything at all/ instrument would not deliver energy.The procedure was converted because the vessel sealer instrument would not work.The customer did not have a back-up vessel sealer instrument at the time.The procedure was completed laparoscopically successfully, and no injury occurred to the patient.The patient is a 51-year-old female, their bmi is (b)(6), white, and not hispanic/latino.On the subsequent procedure, the customer performed a system restart and used a new vessel sealer instrument which worked fine.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the vessel sealer instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation could not reproduce nor confirm the reported complaint "the vessel sealer was not sealing and received an error message".Review of the log shows an instrument disconnection event informational error code 32005 with no error related to a functional issue.The instrument was placed and driven on an in-house system.The instrument passed initialization and passed both the engagement and self-tests.Testing found the instrument exhibiting intuitive motion in all directions with the grips properly opening and closing properly.The instruments functionality (clamping, sealing, cut and unclamp) were verified and passed specification.The instrument operated as expected.The instrument was fully functional.The probable root cause of the alleged customer could not get the vessel sealer instrument to work on the system cannot be established nor determined, as the instrument passed required tests and performed as intended during in-house testing.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: VESSEL SEALER
• 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: 17067789
• Report Number: 2955842-2023-15891
• Device Sequence Number: 15123235
• Product Code: NAY
• UDI-Device Identifier: 10886874111113
• UDI-Public: (01)10886874111113(10)M10190915
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K110639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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: 410322-05
• Device Catalogue Number: 410322
• Device Lot Number: M10190915 131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White