MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI SI ENDOWRIST MEGA NEEDLE DRIVER; SYSTEM SURGICAL COMPUTER CONTROLLED INSTRUMENT

Model Number DA VINCI SI

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Event Description

Broken cable on mega needle driver.No pt harm, device removed from sterile field, isolated and cleaned for return to mfg.

• Brand Name: DA VINCI SI ENDOWRIST MEGA NEEDLE DRIVER
• Type of Device: SYSTEM SURGICAL COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; sunnyvale CA 94086
• MDR Report Key: 8874068
• MDR Text Key: 153845673
• Report Number: MW5088878
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DA VINCI SI
• Device Catalogue Number: 420194-12
• Device Lot Number: N10180921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1