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

Model Number 470194

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

Patient Problem Insufficient Information (4580)

Event Date 11/06/2021

Event Type  malfunction  

Event Description

While the surgeon was using the mega needle driver inside the patient it had broken.There was a wire sticking out of it and broke the needle on the suture that the surgeon was using.Proper management was informed of the issue and the instrument was removed from the field and placed in a red bag for inspection.All counts were correct at the end of the procedure.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12810587
• MDR Text Key: 280750477
• Report Number: 12810587
• 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: 11/08/2021

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: 470194
• Device Catalogue Number: 470194
• Device Lot Number: N11210208 0010
• 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: 11/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33215 DA
• Patient Sex: Female