MAUDE Adverse Event Report: INTUITIVE SURGICAL DA VINCI STAPLER 45

Model Number DA VINCI XI

Device Problems Detachment Of Device Component (1104); Contamination (1120); Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 07/06/2017

Event Type  Injury  

Event Description

The endowrist stapler sheath (ref: (b)(4)) used in the da vinci xi stapler 45 (ref: (b)(4)) to cover the end shaft of the stapler handpiece looks like an original oem part that has always been a part of the stapler.There was no clear warning or bright notice to instruct users to remove the sheath prior to sending to sterile processing department (spd) for reprocessing.The black piece of the sheath happened to disengage from the other part of the sheath and was left on the instrument during this event.The spd team did not notice and the handpiece was sterilized with the part of the sheath intact.The instrument was then used on a case.It was discovered the remaining piece was not part of the stapler handpiece when another sheath was inserted and that the stapler would not fit the cannula.At this point, the instrument becomes contaminated with bioburden (part of the remaining sheath) and the wound classification changes from clean to contaminated.Request that changes to the sheath be made to warn users the sheath must be removed after a case to include a red warning "dispose after use" or changing entire color to make it stand out.

• Brand Name: DA VINCI STAPLER 45
• Type of Device: STAPLER
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 6710596
• MDR Text Key: 80067433
• Report Number: MW5070965
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): Y
• 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: 07/11/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DA VINCI XI
• Device Catalogue Number: 470298
• Device Lot Number: S10161130 0005
• 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): Required Intervention