MAUDE Adverse Event Report: INTUITIVE SURGICAL INTUITIVE SURGICAL DAVINCI; DAVINCI ROBOT SUTURE CUT NEEDLE

Model Number VER05

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

Event Type  malfunction  

Event Description

Instrument inserted into arm 1.Jaws would not open on mega suturecut needle driver.Removed instrument and replaced with new instrument.No harm reached patient.

• Brand Name: INTUITIVE SURGICAL DAVINCI
• Type of Device: DAVINCI ROBOT SUTURE CUT NEEDLE
• Manufacturer (Section D): INTUITIVE SURGICAL; sunnyvale CA
• MDR Report Key: 6489385
• MDR Text Key: 72811979
• Report Number: MW5069059
• Device Sequence Number: 1
• Product Code: NAY
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VER05
• Device Lot Number: N10161006931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 86 YR