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

Model Number 471309

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

Instrument was not working properly thus surgeon decided to have it checked and it was found out that the wire was frayed.

• 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: 13280297
• MDR Text Key: 283942249
• Report Number: 13280297
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• 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: N102011030172
• Was Device Available for Evaluation?: Yes
• 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: 01/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1