MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480422

Device Problems Mechanical Jam (2983); Failure to Seal (4070)

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

Event Date 02/06/2023

Event Type  malfunction  

Event Description

During the robotic-assisted laparoscopic sigmoid colectomy procedure, the intuitive endowrist vessel sealer failed when the device's blade stayed exposed and would not cover up.The device was taken off the field and replaced with a new device that worked without incident.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 16627053
• MDR Text Key: 312124741
• Report Number: 16627053
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115664
• UDI-Public: (01)00886874115664(17)241231(10)L82221228
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422
• Device Catalogue Number: 480422
• Device Lot Number: L82221228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White