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

Model Number 480422-01

Device Problem Melted (1385)

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.A return material authorization (rma) was issued to the customer requesting to have the intuitive device returned.However, isi has not received the product involved with the alleged issue to perform failure analysis.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted if the product is returned (post failure analysis evaluation) or if additional information is received.

Event Description

It was reported that during a da vinci-assisted hiatal hernia paraesophageal surgical procedure, the wires at the tip of the vessel sealer extend (vse) instrument melted.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information.However, no further details have been received as of the date of this report.

Manufacturer Narrative

Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the reporter informed there were no fragments that fell into the patient.The instrument was inspected prior to use with no defects found.The surgeon was dissecting the tissue and grasping when the issue occurred.The surgeon did not lend a theory as to why the instrument started melting.The instrument was in use for 20-30 minutes prior to the issue.No issues were noticed during the functionality of the instrument.The instrument did not collide with any other instruments or material during the procedure.The customer removed the instrument when they noticed the melting and kept it from fragments falling into the patient.The surgical staff did not experience any resistance upon removal of the instrument through the cannula.The wrist was straightened upon removal of the instrument.No additional damage to the cannula or the instrument was observed.No surgical procedure was required to remove fragments.No post op tests or x-rays were performed to check for fragments.The procedure was completed robotically with no injury to the patient.The patient has not returned with any complications.The instrument was returned.The vessel sealer sealed properly.No burning to the patient.An investigation was completed to determine the cause of this reported event.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.A visual inspection was performed, and the instrument displayed no physical damage.No conductor wire damage or snake wrist damage was found.There was a substantial amount of bio debris found at the instrument tips.The instrument passed electrical continuity tests.The instrument was placed and driven on an in-house system and passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The instrument cut and delivered energy with no issue detected.The instrument was fully functional.No failures were found in the logs.No product issue was identified.

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: 17716138
• MDR Text Key: 323062619
• Report Number: 2955842-2023-18352
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)K12230616
• 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,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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: K12230616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 83 KG