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

Model Number 480422-01

Device Problem Difficult to Remove (1528)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the instrument for evaluation.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.Isi received a video clip related to the alleged complaint.In the video, the surgeon was operating with the prograsp forceps in arm 2 and the vse in arm 4.Once the surgeon takes control of the vse, they appear to roll the instrument as they move it towards the target anatomy.Roughly halfway through the video the vse appears to bounce as noted in the complaint.

Event Description

It was reported that during a da vinci-assisted surgical procedure, vessel sealer extend (vse) instrument did not move accordingly to the movements intended by the surgeon.It did a bouncing motion.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer to confirm that the surgeon¿s head was inside the surgeon console¿s high resolution stereo viewer and was attempting to manipulate instruments from the surgeon console.The surgeon confirmed that there was a delay in the movement and the instrument did move in the intended direction.There was no friction experienced.There were no collisions with the arm or instruments.The issue was persistent.The surgeon did not want to risk his patient, so he tried to use the instrument twice only and both times the instrument had the described failure.The surgeon was taking control of the instruments after being inserted into the abdominal cavity by his fa at the beginning of the procedure.The issue was not resolved with the same instrument.After happening again, the surgeon made the decision to continue the surgery with another brand-new vse which worked perfectly.The customer inspected all instrumentation before surgery, the or staff makes sure no cables are loose in the instrument wrist and the jaws had proper movement.There were no issues found and there was no patient injury.The issue occurred about 30 minutes after the start of the procedure.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The vessel sealer extend was analyzed and the complaint was not confirmed by failure analysis.Upon visual and microscopic inspection, no damage was found to the wrist assembly.No cable damage or misalignment of grips was observed.The instrument was placed and driven on an in-house system.The instrument passed the self-test on multiple attempts.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly and performed grip function successfully.The knife cut cleanly through test strip paper.The knife edges were not damaged.Cut test passed.Energy activation test was then conducted on system and passed.No errors occurred during in house testing.Review of logs did not find any errors.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18937855
• MDR Text Key: 338072567
• Report Number: 2955842-2024-12575
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L85231124
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: L85231124 0169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2023
• 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: 46 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White