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

Model Number 470184-14

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The permanent cautery spatula (pcs) instrument was analyzed and found to have a broken yaw pulley at the distal end.Two pieces measuring approximately 0.052" were not returned with the instrument.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the permanent cautery spatula instrument broke in a flexed position.The instrument was unable to be removed from the trocar.The procedure was completed.Intuitive surgical, inc.(isi) followed up and additional information was obtained about the complaint.The instrument was inspected prior to use and nothing out of the ordinary was observed.The instrument and trocar were removed together, and the port incision was increased to do so.No fragment fell inside the patient.There were no instrument/tool collisions.A backup instrument was used to complete the procedure.

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY SPATULA
• 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: 18816600
• MDR Text Key: 336662839
• Report Number: 2955842-2024-11728
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470184-14
• Device Catalogue Number: 470184
• Device Lot Number: K11230706 0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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
• Patient Age: 52 YR
• Patient Sex: Female