MAUDE Adverse Event Report: INTUITVE SURGICAL INTUITIVE SURGICAL; LARGE DAVINCI ST NEEDLE DRIVER

Catalog Number 420006

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

Event Type  malfunction  

Event Description

The housing unit on the large davinci needle driver came apart.Instrument was missing the release clamp, normally found on the side of the housing unit.No patient harm and case proceeded, with having to remove the instrument from the davinci arm.

• Brand Name: INTUITIVE SURGICAL
• Type of Device: LARGE DAVINCI ST NEEDLE DRIVER
• Manufacturer (Section D): INTUITVE SURGICAL; version #08
• MDR Report Key: 6360731
• MDR Text Key: 68503649
• Report Number: MW5068130
• 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: 02/21/2017

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: No Information
• Device Catalogue Number: 420006
• Device Lot Number: N11151008 074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2017
• 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: 75 YR
• Patient Weight: 91