MAUDE Adverse Event Report: INTUITIVE SURGICAL DA VINCI STAPLER; SURGICAL STAPLER AND IMPLANTABLE STAPLES

Model Number 48645B

Device Problems Device Alarm System (1012); Failure to Cut (2587); Device Operates Differently Than Expected (2913)

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

Event Date 10/12/2017

Event Type  Injury  

Event Description

On (b)(6), pt had a right hemicolectomy performed.No issues noted during surgery.On (b)(6), pt brought back to the operating room.Anatomosis was resected and sent to pathology.Pathology revealed that anastomosis had two staple lines but was not cut to create lumen.Suspect stapler malfunction.No lumen was cut when anastomosis was created by using the stapler.No fault messages or error messages were given by robot.

• Brand Name: DA VINCI STAPLER
• Type of Device: SURGICAL STAPLER AND IMPLANTABLE STAPLES
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 6995779
• MDR Text Key: 90931977
• Report Number: MW5073083
• Device Sequence Number: 0
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48645B
• Device Lot Number: M10160211-0257
• 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 Outcome(s): Hospitalization; Required Intervention