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

Model Number 471309

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

While suturing body tissue, the device broke and wires became exposed beyond the device tip.

• Brand Name: ENDOWRIST MEGA SUTURECUT ND
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12959868
• MDR Text Key: 281910492
• Report Number: 12959868
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471309
• Device Lot Number: N102102150314
• 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: 11/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA