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

Model Number 480422-01

Device Problem Energy Output Problem (1431)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Vascular Problem (4441)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.Site history review was conducted on (b)(6) 2021 and did not show any additional complaints related to this event.A request for a procedure video review was submitted to the surgeon of record on (b)(6) 2021 but no procedure video/video clip has been submitted for review at this time.System error log review was conducted by an isi technical support engineer (tse) the day following the initial report of the event on (b)(6) 2021 and found a single engagement 22020 error for the vessel sealer on usm3 but no other vessel sealer errors were observed.Said event was confirmed upon system error log review that was conducted on (b)(6) 2021 for a procedure on (b)(6) 2021 on system sl0371.Additionally, there were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.Single use vessel sealer extend (vse) pn: 480422-01 || ln: l92210210-0084 || sn: (b)(4) was in use for 2:40:39 (2hrs forty minutes and thirty nine seconds) with no additional complaint filed against the instrument upon site history review.While not all reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against those instruments.An isi advanced failure analysts (afa) engineer conducted a vessel sealing instrument log review and results were as follows: while energy event logs were unavailable, instrument error messages were recorded in the logs and reviewed.The vessel sealer extend (vse) ln: l92210210-0084 was installed on the system for 3h 39m and no instrument errors were recorded in the logs.While there was one engagement error 22020 recorded for the wrist pitch axis at 14:41:17, after a reinstall, the instrument passed homing at 14:41:28 and was able to be used successfully afterwards.The described event meets the criteria of a reportable event as the generator used with the vessel sealer extend (vse) instrument and da vinci system is designed to provide a successful confirmation signal to indicate seal completion.It was reported that the vse instrument allegedly did not sufficiently complete a seal even though audible beeps from the generator provided a signal that indicated that the seal was complete.Additionally, the surgeon applied pressure, clamped the vessel, and converted to open surgery.There was approximately 800 ml of blood loss for which one unit of blood was transfused.A surgeon suture ligated the artery to resolve the bleeding and the open surgery successfully completed.At this time, the root cause of the reported failure mode and bleeding event are unknown.Follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.

Event Description

It was initially reported that during a da vinci-assisted right hemicolectomy procedure, there was an alleged ineffective seal with a vessel sealing (vs) instrument.An isi specialty sales manager (ssm) contacted an isi technical support engineer (tse) the following day to report the issue.It was reported that the surgeon attempted to ¿seal a vessel¿ with a vs instrument and that, ¿once the surgeon opened the jaws of the instrument, the vessel burst open and they converted to open¿.The tse viewed system logs and found a single engagement 22020 error for the vessel sealing instrument on usm3 but no other vessel sealing errors were observed.Additional information was unknown at the time of the initial report.On 21-jun-2021, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: during a da vinci-assisted right hemicolectomy procedure, there was an alleged insufficient seal while attempting to ligate and transect the ileocolic artery, which the surgeon skeletonized, with a vessel sealer extend (vse) instrument on an e100 generator.When the surgeon went to make the ¿final seal and vessel transection¿, the vessel ¿hadn¿t sealed as expected¿ so when the surgeon opened the jaws of the vse instrument, there was unexpected bleeding.The surgeon applied pressure, clamped the vessel, and converted to open surgery.There was approximately 800 ml of blood loss for which one unit of blood was transfused.A surgeon suture ligated the artery and the open surgery successfully completed.The patient was reported as doing well.

• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12164528
• MDR Text Key: 261458769
• Report Number: 2955842-2021-10786
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L92210210
• 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: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: L92210210-0084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2021
• Initial Date FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: No
• 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