MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI X SUREFORM 60 STAPLER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 480460

Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

During or robotic case, sureform 60 stapler was inserted into robot arm.Robot made an error alert.'unable to calibrate'.Scrub rn put the stapler in and out of the robot arm several times with no success.She then removed and replaced the instrument drape arm adaptor and retried the stapler.Stapler was still alarming and not working.Circulator called the da vinci help line.Meanwhile the scrub used a hemostat to manually twist the adaptor circles on the robot stapler.She then reinserted the stapler and it worked fine after that for 6 staple loads.Fda safety report id# (b)(4).

• Brand Name: DA VINCI X SUREFORM 60 STAPLER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 15455025
• MDR Text Key: 300322959
• Report Number: MW5112123
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480460
• Device Lot Number: L10220803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female