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

Model Number 471006

Device Problems Break (1069); Material Frayed (1262)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  malfunction  

Event Description

When the large needle driver was placed into the trocar and became visible on the screen it was noticed that there was a wire that broken and frayed.

• Brand Name: ENDOWRIST LARGE NEEDLE DRIVER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12383762
• MDR Text Key: 268698647
• Report Number: 12383762
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471006
• Device Catalogue Number: 471006
• 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: 08/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA