MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. 8MM MEGA SUTURECUT NEEDLE DRIVER XI; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 06/27/2017

Event Type  malfunction  

Event Description

While trying to use the xi davinci large suturecut needle driver, it was noticed that the jaws of the device when opened would get stuck in this position, and not close unless done manually.Therefore the device was not suitable for use.Per manager: possible user error per staff.Staff reeducated on device failure.

• Brand Name: 8MM MEGA SUTURECUT NEEDLE DRIVER XI
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6720905
• MDR Text Key: 80284052
• Report Number: 6720905
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2017
• Event Location: Other
• Date Report to Manufacturer: 07/12/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR