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

Model Number 480460

Device Problem Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

The robotic stapler misfired.The last blue load stapler fire failed to create solid staple lines on either side of the intended field for firing the stapler.

• Brand Name: SUREFORM 60 STAPLER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12845482
• MDR Text Key: 281036296
• Report Number: 12845482
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• 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: L91211011
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female
• Patient Weight: 122 KG