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

Model Number 48/0460

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

A 60 robotic stapler fired successfully 4 times then 60 robotic stapler error intra-operatively stating: "not initializing - reinsert stapler".Reinserted multiple times after cleaning stapler.Attempted with different colored staple loads (white/blue) readjusted arm drape, then replaced drape.Continued error message.Fda safety report id# (b)(4).

• Brand Name: SUREFORM 60
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 13938318
• MDR Text Key: 288182835
• Report Number: MW5108560
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 48/0460
• Device Lot Number: T90220111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male