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

Model Number 480422-01

Device Problem Retraction Problem (1536)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/19/2021

Event Type  Injury  

Event Description

It was initially reported that during a da vinci-assisted right hemicolectomy procedure, the blade of a vessel sealer extend (vse) instrument in arm #3 did not retract.An unspecified error presented.The surgeon tried to remove the vse but bleeding from a vessel occurred.The vse was removed and a new vse was used.There were no other issues.The procedure completed robotically.On 19-mar-2021, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: during a da vinci-assisted right colectomy procedure, an unintended vessel was cut resulting in unexpected bleeding.The surgeon said that the vessel sealer extend (vse) instrument was working but then it stopped working; it ¿froze completely¿ when an unspecified error presented.The surgeon said that he did not hear ¿the usual system tones¿ and that he ¿pulled and tugged and the message cleared¿.Upon the message clearing, the surgeon ¿went to cut¿ what he thought was ¿under the mesentery of the colon¿ but ¿accidentally ended up cutting a branch of the ileocolic vessel instead¿.The surgeon confirmed that he did not hear system tones that it was ok to cut, nor did he see any tissue effect but that he ¿cut anyway¿.There was no long continuous tone with three ¿happy beeps¿.The surgeon said that when the error had cleared, the vse worked like it did before the error and he ¿had full access and could squeeze, cut and seal¿ with the same vse instrument.There was approximately 500cc of unexpected blood loss and no transfusion was required.The surgeon resolved the issue by ¿grabbing the proximal end of the ileocolic vessel with a fenestrated bipolar forceps (fbf) instrument and the distal portion with the vse instrument.A suction irrigator was installed onto the system and bleeding was quickly controlled within approximately two minutes.A backup vse instrument was then installed.There were no other intra-operative complications.The procedure completed robotically with no additional issues and no report of patient injury.The patient was reported as doing well with no post-operative complications.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the vessel sealer extend instrument (pn: 480422-01 || ln: l92200920-0010) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was confirmed but not replicated.The instrument was placed and driven on an in-house system and passed initialization.The instrument moved intuitively with full range of motion in all directions and the grips opened and closed properly.The instrument passed the knife slot test.The instrument was found to have dislodged blade failure based on log review.No conductor wire damage or snake wrist damage was found.No damage was found to the blade or knife cable.There was no bio debris found at the instrument tip.A review of the logs showed one blade exposed failure.The root cause of dislodged instrument blades is typically attributed to the user.System error log review was conducted during the support call and found error ¿vessel sealer blade cannot retract on pctp, toolid 5800887- rfid |log_vs_blade_jammed¿.A review of the instrument logs was performed for a procedure on 19-mar-2021 on system sk0561.Single use vessel sealer extend (vse) pn: 480422-01 || ln: l92200920-0010 || sn: 2009200010 was confirmed by the surgeon as being the instrument involved with this event.While not all other 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 field service engineer (fse) investigation was completed.The fse conducted a site visit and log review.The fse confirmed error 22025, log vs jam blade.The fse tested a vessel sealer extend (vse) on arm3 and there was no trouble found (ntf).The fse was unable to reproduce the reported problem and the system was tested and verified as ready for use.No image or video clip for the reported event was submitted for review.An isi advanced failure analyst (afa) engineer conducted a vessel sealer log review and results were as follows for vessel sealer extend (vse) pn: 480422-01 || ln: l92200920-0010 || sn: 2009200010: the only errors noted were around 10 mins after the vse was initialized.The first errors are jaw_angle_open events, which indicate the system detected the jaws were too far open to allow cutting.This was immediately followed by a failed cut as well as a blade jam and recovery sequence.After the blade recovery, there were 29 seal events (26 of which were auto-stopped) and 3 completed cuts before the instrument was switched out.The completed seals and cuts after the errors suggest that the instrument was able to recover the blade and remain fully functional.There is nothing in the logs that indicate an instrument failure and the logged events are indicative of user related events.The complaint is reportable due to the following: there was no audio tone from the vessel sealer before cutting resulting in excess bleeding.

• 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: 14859934
• MDR Text Key: 295066834
• Report Number: 2955842-2022-12560
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L92200920
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• 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: L92200920 0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2020
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic