MAUDE Adverse Event Report: INTUITIVE SURGICAL STAPLER POWER PACK; DAVINCI ROBOTIC STAPLER

Model Number 372300

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

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

Event Date 04/26/2016

Event Type  malfunction  

Event Description

Message reported, "low pt brought to operating room suite for robotic laparoscopic sleeve gastrectomy.Pt put to sleep and procedure started as usual.Robotic stapler was then inserted for stapling of procedure.First staple cartridge was inserted and closed on stomach.Half way through stapler firing, a fault was thrown on davinci.Davinci error message reported, "low torque from motor pack." emergency wrenches were then utilized to open the jaws of stapler instrument.Jaws were opened and stapler device and cartridge were removed.Stapler device and motor pack were removed from use.A new stapler and motor pack were then going to be utilized.However, there was a problem with the wristing action of the stapler.The new, faulty device was then also removed.An ethicon stapler was utilized to finish the procedure without incident.

• Brand Name: STAPLER POWER PACK
• Type of Device: DAVINCI ROBOTIC STAPLER
• Manufacturer (Section D): INTUITIVE SURGICAL; sunnyvale CA 94086
• MDR Report Key: 5624440
• MDR Text Key: 44345571
• Report Number: MW5062002
• Device Sequence Number: 2
• 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: 04/27/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 372300
• Device Catalogue Number: 372300
• Device Lot Number: 419333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR