MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number 470183-14

Device Problem Melted (1385)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting electrical leakage, 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 permanent cautery hook (pch) instrument was analyzed and found to have thermal damage to the yaw pulley around the sleeve area.The instrument passed the electrical continuity test.Additional observations found that there was thermal damage to the distal clevis.The complaint regarding electrical leakage was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.A review of the provided image was performed by an intuitive surgical, inc.(isi) fae.The following additional information was provided stating there was thermal damage to the distal clevis.

Event Description

It was reported that during a da vinci-assisted sigmoidoscopy surgical procedure, the permanent cautery hook had electrical leakage from the tip of the instrument.It was confirmed no fragment fell inside the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the permanent cautery hook was inspected prior to use and there was no damage observed.The customer was unsure if there was damage to the instrument after the electrical leakage, if arcing occurred, and what surgical task was being performed when the electrical leakage occurred.The instrument was being used for monopolar coag during the event with an erbe generator set at cut 3 and coag 5 for approximately 1 hour.The instrument was connected properly and there was no instrument tip collision with other instruments.The customer doesn't recall what other instruments were in use during the event nor if the instrument was in contact with tissue.The instrument did not touch any staples, clips, or sutures while energized.There was no damage to the surround tissue as a result of the energy leakage and no injury to the patient.The patient has not returned to the hospital.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• 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: 17385619
• MDR Text Key: 319897147
• Report Number: 2955842-2023-17267
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(11)211118(10)K11211122
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: K11211122 0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Single Use?: No
• 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