MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI INTUITIVE MONOPOLAR SCISSORS

Model Number 470179

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

Event Type  malfunction  

Event Description

Pt was having a robot assisted laparoscopic radical prostatectomy with bilateral pelvic lymph node dissection.At the end of the surgery, it was noticed that 4x8mm piece of plastic from da vinci intuitive monopolar scissors was missing.

• Brand Name: DA VINCI INTUITIVE MONOPOLAR SCISSORS
• Type of Device: MONOPOLAR SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; sunnyvale CA 94086
• MDR Report Key: 7104350
• MDR Text Key: 94506115
• Report Number: MW5073866
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470179
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 70 YR
• Patient Weight: 82