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

Model Number 480422

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

Davinci vessel sealer blade malfunctioned and got stuck in the outward position within the jaws of the device.

• 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: 13167828
• MDR Text Key: 283256252
• Report Number: 13167828
• Device Sequence Number: 1
• Product Code: NAY
• 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: 01/04/2022,12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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: M91211101
• 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: 01/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White