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

Model Number 480422-01

Device Problems Off-Label Use (1494); Physical Resistance/Sticking (4012)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the cause of the operative complication cannot be determined.Intuitive surgical, inc.(isi) has not received the vessel sealer extend (vse) instrument involved with this event for failure analysis evaluation.Therefore, the root cause of the customer reported failure mode could not be determined.No image or procedure video was provided for review.A review of the system logs for the event date of (b)(6) 2021 has been performed by an intuitive surgical, inc.(isi) post market surveillance specialist and the following was observed: there were no observed events in the system logs that would suggest a product issue and the logged events are in line with normal system functionality.An isi advanced failure analysis (afa) engineer conducted a vessel sealer log review and there were no vse errors recorded.There were no reports of an instrument failure or an insufficient seal.The logs found that there were 7 instances of the ¿high initial starting impedance¿ message recorded which indicates the impedance of the tissue clamped between the jaws was higher than expected.This is likely due to a clinical factor including but not limited to sealing over already desiccated tissue, tissue type, tissue thickness or fat content.Additionally, with regard to the description of event related to the surgical staff applying ¿e-lube¿ [electrolube/lubricant] on the tips/jaws of the vse instrument when prepping for use, this practice is not on label and cannot be recommended.This complaint is being reported due to the following conclusion: the vse instrument worked in the beginning of the case but began to ¿stick¿ on unspecified tissue when sealing.Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during an unspecified da vinci-assisted gastrectomy procedure, a vessel sealer extend (vse) instrument was ¿sticking to tissue, stuck to a vein¿.The surgeon/surgical staff ¿did inner operative cleaning to troubleshoot but did not work¿.The procedure was completed robotically with the use of a back-up instrument.On 14-sep-2021, intuitive surgical, inc.(isi) obtained the following additional information from the site robotics coordinator regarding the reported event: during a da vinci-assisted gastrectomy procedure, a vessel sealer extend (vse) instrument was ¿sticking to a vein¿.The procedure was completed robotically with use of a back-up instrument with no report of injury.An isi clinical technical associate (cta) who had conversations with the surgeon directly provided the following: the vse was opened and inspected prior to use.The surgical staff applied ¿e-lube¿ [electrolube/lubricant] on the tips/jaws of the vse instrument when prepping for use.When asked, it was unknown why this was performed but that ¿it happens sometimes¿.The vse instrument worked in the beginning of the case but began to ¿stick¿ on unspecified tissue when sealing.The surgical staff cleaned the se instrument and then re-applied e-lube to the vse instrument tips/jaws.The surgeon continued using the vse and later in the procedure, the surgeon met with the same sticking issue but the issue occurred when ¿sealing across the portal vein¿.The surgeon was able to completely seal as desired, with desired tissue effect.There was no report of an alleged insufficient seal but it just felt to the surgeon as if the tips were sticking.A backup vse instrument was used without use of e-lube; upon doing so, there were no further vse sticking issues.The procedure was completed robotically with no adverse event, no bleeding event, and no patient injury.There was no report of insufficient, delayed, or no sealing events.It was reported that proper tissue effect was observed and that the portal vein was under 7mm in diameter.There were no known hard objects causing interference with the sealing cycle and there was no known vessel calcification or tissue tension.There was visible bio-debris at the vse instrument tips but reportedly ¿not out of the norm¿.The surgeon reported to the cta that the sealing sequence of the vse worked as intended with the jaws being closed, the pedal being pressed, and the continuous audible tone with the quick beeps at the end for the sealing cycle being complete.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 14846603
• MDR Text Key: 295121732
• Report Number: 2955842-2022-12513
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)M91210624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: M91210624 0235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES