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	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted pancreatectomy - distal surgical procedure, the vessel sealer (vs) instrument was not firing when surgeon side console (ssc) pedal was pushed.The customer power cycled the system.However; the issue persisted.The surgeon made the decision to convert the procedure to traditional laparoscopic techniques with no injury reported.The customer stated another vs instrument was working as expected during the prior procedure on the same day.A technical support engineer advised the customer to test the electro surgical unit (esu) with the vs emulator.Intuitive surgical, inc.(isi) followed up with the field service engineer (fse) and clinical sales representative obtained the following additional information: the vs instrument (pn# 410322-05 / lot# m10211207-606) never worked during the procedure.The customer did not have a 3rd party backup esu and reportedly the vs instrument was crucial for the procedure.
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The reported complaint was not confirmed based on the field evaluation and verified in the system log files.The fse was unable to reproduce the reported problem.No issues were identified when the esu was tested and the fse was able to fire the vs emulator with the both ssc's.The system was tested and verified as ready for use.A review of the instrument log for the vessel sealer (vs) instrument (410322-05 / lot# m10211207-606) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system rsh0132 for approximately 2 minutes and 30 seconds.The vs was not returned for evaluation.The no images or procedure video was shared for review.A review of the site¿s system logs for the reported procedure date was conducted by the fse.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.This complaint is considered a reportable event due to the following conclusion: the customer converted to traditional laparoscopic surgical techniques after the start of the procedure due to the vs instrument 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.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the vessel sealer instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.Review of the logs found no failures related to the reported instrument.Manual articulation of the grips opened and closed properly.The housing was removed from the back end, no damage was found.The blade and knife cable were inspected, no damage was observed.The instrument was installed on an in-house system and passed initialization.The energy cable was recognized by the generator and a cut test and energy delivery test were both performed and passed on multiple attempts.A grip force test was also performed and passed.There was no problem detected for the customer reported complaint.Additional steps/test attempts to further support the finding passed with no issues.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• 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: 14058267
• Report Number: 2955842-2022-10950
• Device Sequence Number: 4925577
• Product Code: NAY
• UDI-Device Identifier: 00886874110799
• UDI-Public: (01)00886874110799
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/10/2022
• 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