MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST MONOPOLAR SCISSORS; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Lot Number N10170523

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2019

Event Type  malfunction  

Event Description

During midway through a robotic prostatectomy, the jaws of the device stopped working.At the time it was discovered, the monopolar scissors were not attached to any tissue.The device was removed from the field.No patient injury.

• Brand Name: ENDOWRIST MONOPOLAR SCISSORS
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 8662286
• MDR Text Key: 146814328
• Report Number: 8662286
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: N10170523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23725 DA