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

Model Number 471309

Device Problem Entrapment of Device (1212)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2021

Event Type  malfunction  

Event Description

Suture string (not needle) got caught in instrument and surgeon could not get it out of the instrument.

• 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: 11337197
• MDR Text Key: 232170457
• Report Number: 11337197
• 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: 02/09/2021

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: Health Professional
• Device Model Number: 471309
• Device Catalogue Number: 471309
• Device Lot Number: N10201006
• 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: 02/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Weight: 91