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

Model Number 480422-01

Device Problem Failure to Sense (1559)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 01/18/2024

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted surgical procedure, bleeding occurred from tissue sticking to the jaws of the vessel sealer extend (vse) instrument.After multiple uses of the vse instrument for coagulation, tissue began to stick to the jaws of the instrument.Then when the surgeon would open the jaws of the instrument, tissue damage and bleeding occurred; requiring the surgeon to perform additional coagulation and staff to clean the instrument jaws more frequently.The blood loss was less than 200ml and the patient did not require a blood transfusion.The surgeon stated the reported event appeared to occur after three to eight times of triggering the vse instrument; or after two to six minutes of use of the instrument.The procedure was completed and there were no post operative complications.Intuitive surgical, inc.(isi) contacted the site for additional information; however, at the time of this report, no further details have been provided.

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.Intuitive surgical, inc (isi) did not receive the vessel sealer extend (vse) instrument that was used during this reported event; therefore, failure analysis investigations (fa) could not be performed.Verification of the event details cannot be performed via system logs because on site connectivity is not available at this time and there's insufficient surgeon and case 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: 18727370
• MDR Text Key: 335693166
• Report Number: 2955842-2024-11452
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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