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

Model Number 480422-01

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the vessel sealer extend (vse) instrument involved with this complaint and completed the device evaluation.The instrument was found to have a dislodged blade failure based on log review.A visual inspection revealed that the blade was not exposed outside of the blade garage.No conductor wire damage or snake wrist damage was found.There was no bio debris found on the instruments tip.A review of the logs revealed one blade exposed failure.The root cause of the dislodged instruments blade is typically attributed to mishandling/misuse.The instrument was placed and driven on an in-house system.The instrument passed the self-test homing.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly and the instrument passed the knife slot test.Additionally, the instrument was found to have a dislodged ceramic dot of the grip at the distal end.The dislodged material was not returned with the instrument.Root cause of this failure is attributed to mishandling/misuse.A review of the instrument log was performed.Per the review, the vse instrument, sn: (b)(4) was used on system (b)(4) on (b)(6) 2022 with 0 lives remaining.A review of the site's complaint history identified no other complaints related to the instrument and/or this event.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: failure analysis acknowledges that a fragment was missing from a portion of the device that enters the patient (distal end).Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during the procedure.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but 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 a da vinci-assisted total benign hysterectomy surgical procedure, about 15 minutes into using the vessel sealer extend (vse) instrument to seal tissue, the customer received an alert that the blade was exposed.The procedure was continuing as planned with no reported injury.Follow up was performed with the customer and additional information was obtained.The robotics coordinator stated that the instrument involved was not inspected prior to use, and that they had not been advised to examine each disposable instrument after opening.Per the customer's response, the issue occurred during sealing and cutting; the instrument was not sealing properly/adequately.The customer further stated that the surgeon stated he noticed the sealing was good at times, and not so good at other times.Then he reportedly took a decent bite of thick tissue and the robot screen said ¿blade may be exposed, remove instrument¿ and that is what the team did.The surgeon stated the tones were like they always are.As to whether tissue was cut that was not fully sealed, the customer stated that was unlikely since the surgeon was paying close attention to the tension, tones and sealing/cutting features; also due to the surgeon's familiarity with the instrument, it was unlikely that the target tissue was under tension.The customer stated the surgeon does not know what caused the issue with the vse, and the procedure was completed without further incident.

• 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: 14235024
• MDR Text Key: 290266769
• Report Number: 2955842-2022-11287
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)M91211123
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: M91211123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA2022-01-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White