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

Model Number 480422-01

Device Problem Failure to Deliver Energy (1211)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/25/2021

Event Type  Injury  

Event Description

It was reported by the surgeon that during a da vinci-assisted pancreaticoduodenectomy surgical procedure, the vessel sealer extend (vse) instrument was used for over two hours and was working as expected.However, it later was used to seal a large branch of the portal vein and upon cutting the tissue, it bled.Additionally, when the event occurred, the instrument's blade allegedly jammed.There were no signs of issues during the sealing process for this tissue.When the event occurred, the erbe generated an error stating the vse blade was exposed.The surgeon stated he was unable to immediately open the instrument jaws and could see the blade exposed.The jaws were eventually opened by manipulating the instrument.There was no need to use another instrument or tool to pry the jaws open.Once the tissue was released from the instrument's jaws, the surgeon was able to address the bleeding with other instruments.The surgeon stated a few hundred cc¿s of blood were lost and reported the patient received a blood transfusion.Another vse instrument was used to complete the procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the vse instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests and moved intuitively with full range of motion in all directions.The grips opened and closed properly.Upon visual inspection, the jaw ceramic dots were present.Energy was delivered without any issues and the instrument passed the cut test.The electrical continuity test passed.Jaw gap test passed with the 0.003" gauge and the grip force test passed.The reported issue was deemed to be related to non-device-related factors.An additional finding related to the customer reported complaint was also identified.The vse instrument was found to have a dislodged blade.Visual inspection showed that the blade was exposed outside of the blade garage 0.140".No conductor wire damage or snake wrist damage was found.The blade was manually retracted.The root cause of the dislodged instrument blades is typically attributed to mishandling/misuse.A review of the site's complaint history showed no other complaints for this product.No image or procedure video was provided.A review of the instrument log for the vse instrument (part # 480422-01 lot #m91201117-0182) associated with this event has been performed.Per logs, the vse instrument was used on (b)(6) 2021 on system sk2980 for approximately 2 hours and 37 minutes.This device is a single-use instrument and therefore only had one use allotted to it.This reported issue occurred on the instrument's only allotted usage.A failure analysis engineer reviewed the vessel sealer logs for this event and the following information was provided: "this appears to be a typical exposed blade event.There was a failed cut, followed by an unsuccessful recovery sequence resulting in a blade jam message triggered with a p0 value of 1, indicating the blade was declared as jammed outside of the garage (exposed).At this time, the blade exposed message displayed on the system ui.The last message of the 4 recorded was the blade recovery event, which is used to track the time from blade jam acknowledgement (arm swap pressed) to when the blade returns to the garage.However, nothing in the logs suggests there may have been an unclamping issue.Once the blade exposed message appears and is acknowledged, full control of the instrument (eg.Opening/closing) should be returned to the user.I am unsure why they experienced an unclamping issue in this case.In the system logs, we can see that the system recognized the blade was exposed, but nothing further.There are no messages associated with pressing e-stop or using the grip release lever without pressing the e-stop button." based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the vse instrument insufficiently sealed a vessel which resulted with bleeding upon being cut.The patient received blood transfusions due to this event.

• 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: 12970013
• MDR Text Key: 287589738
• Report Number: 2955842-2021-11704
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)M91201117
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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: M91201117 0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2020
• 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