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

Model Number 480422-01

Device Problems Material Fragmentation (1261); Melted (1385)

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

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the area surrounding the vessel sealer jaws appeared to have melted.The issue seems to have occurred during the case as it was not like this when instrument first opened.White pieces came off and into the patient.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use, and no damage was noted.The instrument did not collide with other instruments or hard material during the surgical procedure.No post-operative tests like an x-ray or ultrasound were performed after the procedure.The procedure was completed robotically.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.The surgeon said that the operation room (or) nurse reported the complaint.The surgeon does not think anything was melting, but more likely that excess lubricant was extruding.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The vessel sealer instrument was analyzed, and the reported failure was not confirmed.The visual inspection found no damage to the instrument.There were no melted components identified on the instrument.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument successfully sealed and cut.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.A review of the logs found no failure errors.There was no problem detected for the customer reported complaint.Additionally, the complaint "white pieces came off and into the patient" was confirmed.The white substance located at the distal end of the instrument has previously been identified by manufacturing as krytox lubricant does not affect functionality.No product issue was identified.

• 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: 18897676
• MDR Text Key: 337591875
• Report Number: 2955842-2024-12212
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)K12231014
• 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: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: K12231014 0265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES