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

Model Number 480422

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2023

Event Type  Injury  

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 instrument during this reported event for failure analysis investigations.

Event Description

It was reported that after a da vinci-assisted paraesophageal hernia surgical procedure, the patient bled post-operatively requiring additional surgery.Intuitive surgical, inc.(isi) has attempted to obtain additional information; however, as of the date of this report, no further details have been received.

• 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: 18113743
• MDR Text Key: 327882082
• Report Number: 2955842-2023-20013
• Device Sequence Number: 1
• Product Code: NAY
• 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,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/13/2023

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: 480422
• Device Catalogue Number: 480422
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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